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FDA grants orphan drug status to rofecoxib for hemophilic arthropathy
The Food and Drug Administration on Nov. 21 granted orphan drug designation to rofecoxib (TRM-201), a cyclooxygenase 2–selective nonsteroidal anti-inflammatory drug (NSAID) intended to treat patients with hemophilic arthropathy (HA).
HA, a joint disease caused by hemarthrosis, is the largest cause of morbidity for hemophilia patients. There are currently no approved treatments in the United States.
The attempt at a reintroduction of rofecoxib specifically for the treatment of HA is being developed by Tremeau Pharmaceuticals.
Patients with hemophilia look to avoid traditional NSAIDs, as those drugs risk gastrointestinal ulcers and impair platelet aggregation. The current standard of care for HA is opioid treatment.
Rofecoxib and other NSAIDs cause an increased risk of serious cardiovascular thrombotic events and gastrointestinal adverse events.
Orphan drug status is available to treatments for rare disorders and provides a 7-year marketing exclusivity period against competition, along with tax credits and a waiver of Prescription Drug User Fee Act filing fees.
The Food and Drug Administration on Nov. 21 granted orphan drug designation to rofecoxib (TRM-201), a cyclooxygenase 2–selective nonsteroidal anti-inflammatory drug (NSAID) intended to treat patients with hemophilic arthropathy (HA).
HA, a joint disease caused by hemarthrosis, is the largest cause of morbidity for hemophilia patients. There are currently no approved treatments in the United States.
The attempt at a reintroduction of rofecoxib specifically for the treatment of HA is being developed by Tremeau Pharmaceuticals.
Patients with hemophilia look to avoid traditional NSAIDs, as those drugs risk gastrointestinal ulcers and impair platelet aggregation. The current standard of care for HA is opioid treatment.
Rofecoxib and other NSAIDs cause an increased risk of serious cardiovascular thrombotic events and gastrointestinal adverse events.
Orphan drug status is available to treatments for rare disorders and provides a 7-year marketing exclusivity period against competition, along with tax credits and a waiver of Prescription Drug User Fee Act filing fees.
The Food and Drug Administration on Nov. 21 granted orphan drug designation to rofecoxib (TRM-201), a cyclooxygenase 2–selective nonsteroidal anti-inflammatory drug (NSAID) intended to treat patients with hemophilic arthropathy (HA).
HA, a joint disease caused by hemarthrosis, is the largest cause of morbidity for hemophilia patients. There are currently no approved treatments in the United States.
The attempt at a reintroduction of rofecoxib specifically for the treatment of HA is being developed by Tremeau Pharmaceuticals.
Patients with hemophilia look to avoid traditional NSAIDs, as those drugs risk gastrointestinal ulcers and impair platelet aggregation. The current standard of care for HA is opioid treatment.
Rofecoxib and other NSAIDs cause an increased risk of serious cardiovascular thrombotic events and gastrointestinal adverse events.
Orphan drug status is available to treatments for rare disorders and provides a 7-year marketing exclusivity period against competition, along with tax credits and a waiver of Prescription Drug User Fee Act filing fees.
FDA approves first-in-class drug for hemophilia A with Factor VIII
The Food and Drug Administration has approved emicizumab-kxwh (Hemlibra) for the prevention or reduction of bleeding episodes for adult and pediatric patients with hemophilia A with Factor VIII inhibitors.
The drug received the FDA’s Priority Review, Breakthrough Therapy, and Orphan Drug designations.
It was shown to be safe and effective in two clinical trials, one of boys and men aged 12 years and older and the other of boys younger than 12 years. In the first trial, patients taking emicizumab-kxwh had an 87% reduction in the rate of treated bleeding episodes per year, compared with patients not receiving prophylactic treatment (2.9 vs. 23.3; P less than .0001).
In the second trial, 87% of the children receiving emicizumab-kxwh did not experience a bleeding episode that required treatment.
The most common adverse events were injection site reactions, headache, and arthralgia. The drug labeling includes a boxed warning about the possibility of thrombotic microangiopathy and thromboembolism in patients given an activated prothrombin complex concentrate rescue treatment for 24 hours or more while taking emicizumab-kxwh.
The Food and Drug Administration has approved emicizumab-kxwh (Hemlibra) for the prevention or reduction of bleeding episodes for adult and pediatric patients with hemophilia A with Factor VIII inhibitors.
The drug received the FDA’s Priority Review, Breakthrough Therapy, and Orphan Drug designations.
It was shown to be safe and effective in two clinical trials, one of boys and men aged 12 years and older and the other of boys younger than 12 years. In the first trial, patients taking emicizumab-kxwh had an 87% reduction in the rate of treated bleeding episodes per year, compared with patients not receiving prophylactic treatment (2.9 vs. 23.3; P less than .0001).
In the second trial, 87% of the children receiving emicizumab-kxwh did not experience a bleeding episode that required treatment.
The most common adverse events were injection site reactions, headache, and arthralgia. The drug labeling includes a boxed warning about the possibility of thrombotic microangiopathy and thromboembolism in patients given an activated prothrombin complex concentrate rescue treatment for 24 hours or more while taking emicizumab-kxwh.
The Food and Drug Administration has approved emicizumab-kxwh (Hemlibra) for the prevention or reduction of bleeding episodes for adult and pediatric patients with hemophilia A with Factor VIII inhibitors.
The drug received the FDA’s Priority Review, Breakthrough Therapy, and Orphan Drug designations.
It was shown to be safe and effective in two clinical trials, one of boys and men aged 12 years and older and the other of boys younger than 12 years. In the first trial, patients taking emicizumab-kxwh had an 87% reduction in the rate of treated bleeding episodes per year, compared with patients not receiving prophylactic treatment (2.9 vs. 23.3; P less than .0001).
In the second trial, 87% of the children receiving emicizumab-kxwh did not experience a bleeding episode that required treatment.
The most common adverse events were injection site reactions, headache, and arthralgia. The drug labeling includes a boxed warning about the possibility of thrombotic microangiopathy and thromboembolism in patients given an activated prothrombin complex concentrate rescue treatment for 24 hours or more while taking emicizumab-kxwh.
Carefully monitor cannabis-using patients in opioid-agonist therapy
Canada has passed legislation that will lead to legalization of cannabis for recreational use. Researchers disagree about the public health effects that legalization will have. Alexandra M. Franklyn and her coinvestigators at the Northern Ontario School of Medicine, Sudbury, designed their study to look at one population that might be at risk of cannabis-related harms.
Of 644 patients, 328 (50.9%) were baseline cannabis users. Baseline users were 38.9% more likely to drop out of OAT. Heavy cannabis users (n = 256; 39.8%) were 48.1% more likely to drop out of OAT than those who weren’t heavy users. Heavy users are “a group that should be carefully monitored throughout treatment,” regardless of whether the cannabis use can be considered another substance use disorder or if it is intended to self-medicate another condition that may make dropout more likely, Ms. Franklyn and her colleagues concluded.
“While studies have shown a potential for cannabis legalization to be a positive change for the population as a whole, there may be unique implications for those patients receiving OAT. ... These patients should receive education surrounding the potential harms of cannabis use, including worsened OAT outcomes,” the researchers wrote (PLoS One. 2017 Nov 8;12[11]:e0187633).
Neither Ms. Franklyn nor her colleagues had conflicts of interest to disclose.
Canada has passed legislation that will lead to legalization of cannabis for recreational use. Researchers disagree about the public health effects that legalization will have. Alexandra M. Franklyn and her coinvestigators at the Northern Ontario School of Medicine, Sudbury, designed their study to look at one population that might be at risk of cannabis-related harms.
Of 644 patients, 328 (50.9%) were baseline cannabis users. Baseline users were 38.9% more likely to drop out of OAT. Heavy cannabis users (n = 256; 39.8%) were 48.1% more likely to drop out of OAT than those who weren’t heavy users. Heavy users are “a group that should be carefully monitored throughout treatment,” regardless of whether the cannabis use can be considered another substance use disorder or if it is intended to self-medicate another condition that may make dropout more likely, Ms. Franklyn and her colleagues concluded.
“While studies have shown a potential for cannabis legalization to be a positive change for the population as a whole, there may be unique implications for those patients receiving OAT. ... These patients should receive education surrounding the potential harms of cannabis use, including worsened OAT outcomes,” the researchers wrote (PLoS One. 2017 Nov 8;12[11]:e0187633).
Neither Ms. Franklyn nor her colleagues had conflicts of interest to disclose.
Canada has passed legislation that will lead to legalization of cannabis for recreational use. Researchers disagree about the public health effects that legalization will have. Alexandra M. Franklyn and her coinvestigators at the Northern Ontario School of Medicine, Sudbury, designed their study to look at one population that might be at risk of cannabis-related harms.
Of 644 patients, 328 (50.9%) were baseline cannabis users. Baseline users were 38.9% more likely to drop out of OAT. Heavy cannabis users (n = 256; 39.8%) were 48.1% more likely to drop out of OAT than those who weren’t heavy users. Heavy users are “a group that should be carefully monitored throughout treatment,” regardless of whether the cannabis use can be considered another substance use disorder or if it is intended to self-medicate another condition that may make dropout more likely, Ms. Franklyn and her colleagues concluded.
“While studies have shown a potential for cannabis legalization to be a positive change for the population as a whole, there may be unique implications for those patients receiving OAT. ... These patients should receive education surrounding the potential harms of cannabis use, including worsened OAT outcomes,” the researchers wrote (PLoS One. 2017 Nov 8;12[11]:e0187633).
Neither Ms. Franklyn nor her colleagues had conflicts of interest to disclose.
FROM PLOS ONE
FDA approves cariprazine for schizophrenia maintenance treatment
The Food and Drug Administration has approved a supplemental new drug application for cariprazine (Vraylar) for maintenance treatment of adults with schizophrenia, the drug’s licensor, Allergan, announced Nov. 13. The drug was approved in 2015 for the acute treatment of schizophrenia or for manic or mixed episodes of bipolar I disorder in adults.
The efficacy of the atypical antipsychotic for maintenance treatment of schizophrenia was demonstrated by a 72-week multinational, double-blind, randomized study of a stabilized cariprazine dose of 3, 6, or 9 mg daily, compared with placebo. The daily dose had a significant effect on the study’s primary endpoint – time to relapse. Nearly twice as many placebo-treated patients as cariprazine-treated patients relapsed (49.5% vs. 29.7%).
“The goal of clinicians is to minimize relapses, which can cause significant personal distress and can often have serious implications for a patient’s health,” said Herbert Y. Meltzer, MD, professor of psychiatry and behavioral sciences, pharmacology, and physiology, at Northwestern University, Chicago, in the release. “The approval of Vraylar for the maintenance treatment of schizophrenia provides an important therapy for patients and physicians who are in need of long-term treatment options.”
Cariprazine may cause rash, pruritus, urticaria, and events suggestive of angioedema and is not approved for patients with dementia-related psychosis, as it has an increased mortality risk for elderly patients with dementia. In approved schizophrenia patients, it carries a risk of extrapyramidal symptoms and akathisia.
The Food and Drug Administration has approved a supplemental new drug application for cariprazine (Vraylar) for maintenance treatment of adults with schizophrenia, the drug’s licensor, Allergan, announced Nov. 13. The drug was approved in 2015 for the acute treatment of schizophrenia or for manic or mixed episodes of bipolar I disorder in adults.
The efficacy of the atypical antipsychotic for maintenance treatment of schizophrenia was demonstrated by a 72-week multinational, double-blind, randomized study of a stabilized cariprazine dose of 3, 6, or 9 mg daily, compared with placebo. The daily dose had a significant effect on the study’s primary endpoint – time to relapse. Nearly twice as many placebo-treated patients as cariprazine-treated patients relapsed (49.5% vs. 29.7%).
“The goal of clinicians is to minimize relapses, which can cause significant personal distress and can often have serious implications for a patient’s health,” said Herbert Y. Meltzer, MD, professor of psychiatry and behavioral sciences, pharmacology, and physiology, at Northwestern University, Chicago, in the release. “The approval of Vraylar for the maintenance treatment of schizophrenia provides an important therapy for patients and physicians who are in need of long-term treatment options.”
Cariprazine may cause rash, pruritus, urticaria, and events suggestive of angioedema and is not approved for patients with dementia-related psychosis, as it has an increased mortality risk for elderly patients with dementia. In approved schizophrenia patients, it carries a risk of extrapyramidal symptoms and akathisia.
The Food and Drug Administration has approved a supplemental new drug application for cariprazine (Vraylar) for maintenance treatment of adults with schizophrenia, the drug’s licensor, Allergan, announced Nov. 13. The drug was approved in 2015 for the acute treatment of schizophrenia or for manic or mixed episodes of bipolar I disorder in adults.
The efficacy of the atypical antipsychotic for maintenance treatment of schizophrenia was demonstrated by a 72-week multinational, double-blind, randomized study of a stabilized cariprazine dose of 3, 6, or 9 mg daily, compared with placebo. The daily dose had a significant effect on the study’s primary endpoint – time to relapse. Nearly twice as many placebo-treated patients as cariprazine-treated patients relapsed (49.5% vs. 29.7%).
“The goal of clinicians is to minimize relapses, which can cause significant personal distress and can often have serious implications for a patient’s health,” said Herbert Y. Meltzer, MD, professor of psychiatry and behavioral sciences, pharmacology, and physiology, at Northwestern University, Chicago, in the release. “The approval of Vraylar for the maintenance treatment of schizophrenia provides an important therapy for patients and physicians who are in need of long-term treatment options.”
Cariprazine may cause rash, pruritus, urticaria, and events suggestive of angioedema and is not approved for patients with dementia-related psychosis, as it has an increased mortality risk for elderly patients with dementia. In approved schizophrenia patients, it carries a risk of extrapyramidal symptoms and akathisia.
Some children with HIV may not get enough medical care
, according to researchers at the Centers for Disease Control and Prevention
The investigators examined claims cohorts of children aged 13 years and younger who had been diagnosed with HIV to track their retention of medical care over a 36-month period, starting in 2010. They found that rates of retention in care – defined as at least one visit in every 6-month period – were lower than expected.
However, because rates of AIDS diagnoses and deaths among children are low nationally – an estimated 2,477 children younger than 13 years had HIV in 2014 – it may be that “failure to meet the retention in care definition ... does not necessarily mean loss to follow-up,” cautioned Mary R. Tanner, MD, of the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, and her coinvestigators (MMWR. 2017 Oct 6:66[39];1033-8).
In addition, in the Medicaid claims cohort, 59% of the children who were not retained in care during the first 24 months (but who remained in the study) were in care during months 25-36.
The researchers used the 2010-2014 MarketScan Multi-State Medicaid and MarketScan Commercial Claims and Encounters databases to make cohorts of Medicaid and commercial claims of 163 and 129 children, respectively. They tracked retention of care for these children starting from the first reported ICD-9-CM code for HIV or AIDS. One reason for the current study is that the National HIV Surveillance System, which has a goal of increasing retention in care, does not track children with HIV infection in its progress indicators.
In the first 24 months, 60% of the Medicaid cohort and 69% of the commercial claims cohort were retained in care. For children who remained in the study after month 24, the investigators further divided the cohorts into subgroups of those who remained in care thus far and those who did not. A total of 93% of those in the Medicaid cohort who remained in care during the first 24 months stayed in care in months 25-36, while 59% of those who didn’t remain in care in the first 24 months did remain in care during months 25-36.
For the subgroups in the commercial claims cohort, the same numbers were 85% and 32%.
Noting many possible limitations to the current study, the investigators nevertheless remarked that “overall, the fact that greater than 25% of children with diagnosed HIV infection did not meet the retention in care definition suggests that portions of this medically vulnerable population are not receiving the recommended frequency of medical care.”
, according to researchers at the Centers for Disease Control and Prevention
The investigators examined claims cohorts of children aged 13 years and younger who had been diagnosed with HIV to track their retention of medical care over a 36-month period, starting in 2010. They found that rates of retention in care – defined as at least one visit in every 6-month period – were lower than expected.
However, because rates of AIDS diagnoses and deaths among children are low nationally – an estimated 2,477 children younger than 13 years had HIV in 2014 – it may be that “failure to meet the retention in care definition ... does not necessarily mean loss to follow-up,” cautioned Mary R. Tanner, MD, of the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, and her coinvestigators (MMWR. 2017 Oct 6:66[39];1033-8).
In addition, in the Medicaid claims cohort, 59% of the children who were not retained in care during the first 24 months (but who remained in the study) were in care during months 25-36.
The researchers used the 2010-2014 MarketScan Multi-State Medicaid and MarketScan Commercial Claims and Encounters databases to make cohorts of Medicaid and commercial claims of 163 and 129 children, respectively. They tracked retention of care for these children starting from the first reported ICD-9-CM code for HIV or AIDS. One reason for the current study is that the National HIV Surveillance System, which has a goal of increasing retention in care, does not track children with HIV infection in its progress indicators.
In the first 24 months, 60% of the Medicaid cohort and 69% of the commercial claims cohort were retained in care. For children who remained in the study after month 24, the investigators further divided the cohorts into subgroups of those who remained in care thus far and those who did not. A total of 93% of those in the Medicaid cohort who remained in care during the first 24 months stayed in care in months 25-36, while 59% of those who didn’t remain in care in the first 24 months did remain in care during months 25-36.
For the subgroups in the commercial claims cohort, the same numbers were 85% and 32%.
Noting many possible limitations to the current study, the investigators nevertheless remarked that “overall, the fact that greater than 25% of children with diagnosed HIV infection did not meet the retention in care definition suggests that portions of this medically vulnerable population are not receiving the recommended frequency of medical care.”
, according to researchers at the Centers for Disease Control and Prevention
The investigators examined claims cohorts of children aged 13 years and younger who had been diagnosed with HIV to track their retention of medical care over a 36-month period, starting in 2010. They found that rates of retention in care – defined as at least one visit in every 6-month period – were lower than expected.
However, because rates of AIDS diagnoses and deaths among children are low nationally – an estimated 2,477 children younger than 13 years had HIV in 2014 – it may be that “failure to meet the retention in care definition ... does not necessarily mean loss to follow-up,” cautioned Mary R. Tanner, MD, of the National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention, and her coinvestigators (MMWR. 2017 Oct 6:66[39];1033-8).
In addition, in the Medicaid claims cohort, 59% of the children who were not retained in care during the first 24 months (but who remained in the study) were in care during months 25-36.
The researchers used the 2010-2014 MarketScan Multi-State Medicaid and MarketScan Commercial Claims and Encounters databases to make cohorts of Medicaid and commercial claims of 163 and 129 children, respectively. They tracked retention of care for these children starting from the first reported ICD-9-CM code for HIV or AIDS. One reason for the current study is that the National HIV Surveillance System, which has a goal of increasing retention in care, does not track children with HIV infection in its progress indicators.
In the first 24 months, 60% of the Medicaid cohort and 69% of the commercial claims cohort were retained in care. For children who remained in the study after month 24, the investigators further divided the cohorts into subgroups of those who remained in care thus far and those who did not. A total of 93% of those in the Medicaid cohort who remained in care during the first 24 months stayed in care in months 25-36, while 59% of those who didn’t remain in care in the first 24 months did remain in care during months 25-36.
For the subgroups in the commercial claims cohort, the same numbers were 85% and 32%.
Noting many possible limitations to the current study, the investigators nevertheless remarked that “overall, the fact that greater than 25% of children with diagnosed HIV infection did not meet the retention in care definition suggests that portions of this medically vulnerable population are not receiving the recommended frequency of medical care.”
FROM MMWR
FDA approves letermovir for CMV prophylaxis
The Food and Drug Administration on Nov. 8 approved the use of letermovir (Prevymis) tablets and injections for the prevention of cytomegalovirus (CMV) infection and disease in adults exposed to the virus who have received an allogeneic hematopoietic stem cell transplant (HSCT). This is the first drug to be approved for this purpose. It had previously been granted Breakthrough Therapy and Orphan Drug designation.
CMV infection is a major risk for patients undergoing HSCT, because an estimated 65%-80% of these patients already have been exposed to the virus.
Side effects associated with the use of letermovir include nausea, diarrhea, vomiting, swelling in the arms and legs, cough, headache, tiredness, and abdominal pain. The drug is contraindicated for patients receiving pimozide and ergot alkaloids, or pitavastatin or simvastatin when coadministered with cyclosporine. Prescribing information is available at the FDA website.
The Food and Drug Administration on Nov. 8 approved the use of letermovir (Prevymis) tablets and injections for the prevention of cytomegalovirus (CMV) infection and disease in adults exposed to the virus who have received an allogeneic hematopoietic stem cell transplant (HSCT). This is the first drug to be approved for this purpose. It had previously been granted Breakthrough Therapy and Orphan Drug designation.
CMV infection is a major risk for patients undergoing HSCT, because an estimated 65%-80% of these patients already have been exposed to the virus.
Side effects associated with the use of letermovir include nausea, diarrhea, vomiting, swelling in the arms and legs, cough, headache, tiredness, and abdominal pain. The drug is contraindicated for patients receiving pimozide and ergot alkaloids, or pitavastatin or simvastatin when coadministered with cyclosporine. Prescribing information is available at the FDA website.
The Food and Drug Administration on Nov. 8 approved the use of letermovir (Prevymis) tablets and injections for the prevention of cytomegalovirus (CMV) infection and disease in adults exposed to the virus who have received an allogeneic hematopoietic stem cell transplant (HSCT). This is the first drug to be approved for this purpose. It had previously been granted Breakthrough Therapy and Orphan Drug designation.
CMV infection is a major risk for patients undergoing HSCT, because an estimated 65%-80% of these patients already have been exposed to the virus.
Side effects associated with the use of letermovir include nausea, diarrhea, vomiting, swelling in the arms and legs, cough, headache, tiredness, and abdominal pain. The drug is contraindicated for patients receiving pimozide and ergot alkaloids, or pitavastatin or simvastatin when coadministered with cyclosporine. Prescribing information is available at the FDA website.
FDA approves implantable device for central sleep apnea
The U.S. Food and Drug Administration on Oct. 6 approved an implantable device for the treatment of moderate to severe central sleep apnea.
The remedē System consists of a battery pack and small, thin wires placed under the skin in the upper chest area. The wires are inserted into the blood vessels in the chest to stimulate the phrenic nerve. The system monitors respiratory signals and, when it stimulates the nerve, the diaphragm moves to restore normal breathing.
The agency’s approval comes on the basis of study results showing that the system reduced the apnea–hypopnea index scores by 50% or more in 51% of patients studied. Control patients in the study saw an 11% reduction in their score.
Adverse events reported in the study included concomitant device interaction, implant site infection, and swelling and local tissue damage or pocket erosion. The remedē System is contraindicated for patients with active infection or who are known to require an MRI.
The U.S. Food and Drug Administration on Oct. 6 approved an implantable device for the treatment of moderate to severe central sleep apnea.
The remedē System consists of a battery pack and small, thin wires placed under the skin in the upper chest area. The wires are inserted into the blood vessels in the chest to stimulate the phrenic nerve. The system monitors respiratory signals and, when it stimulates the nerve, the diaphragm moves to restore normal breathing.
The agency’s approval comes on the basis of study results showing that the system reduced the apnea–hypopnea index scores by 50% or more in 51% of patients studied. Control patients in the study saw an 11% reduction in their score.
Adverse events reported in the study included concomitant device interaction, implant site infection, and swelling and local tissue damage or pocket erosion. The remedē System is contraindicated for patients with active infection or who are known to require an MRI.
The U.S. Food and Drug Administration on Oct. 6 approved an implantable device for the treatment of moderate to severe central sleep apnea.
The remedē System consists of a battery pack and small, thin wires placed under the skin in the upper chest area. The wires are inserted into the blood vessels in the chest to stimulate the phrenic nerve. The system monitors respiratory signals and, when it stimulates the nerve, the diaphragm moves to restore normal breathing.
The agency’s approval comes on the basis of study results showing that the system reduced the apnea–hypopnea index scores by 50% or more in 51% of patients studied. Control patients in the study saw an 11% reduction in their score.
Adverse events reported in the study included concomitant device interaction, implant site infection, and swelling and local tissue damage or pocket erosion. The remedē System is contraindicated for patients with active infection or who are known to require an MRI.
Not recommending LAIV didn’t reduce flu vaccination in Oregon children
Oregon researchers studying the effect of not recommending intranasal live attenuated influenza vaccines (LAIV) in favor of injected influenza vaccines (IIV) for the 2016-2017 flu season found that the change in recommendation had a minimal impact on overall flu vaccination rates, but that patients who had been given injected flu vaccine previously were slightly more likely to return for it the following season.
Steve G. Robison, MPH, of the Immunization Program of the Oregon Health Authority in Salem, led the study to monitor the effects of the new recommendation in Oregon, where he and his coauthors noted that there is “a substantial vaccine-hesitant population” (Pediatrics. 2017 Oct 6. doi: 10.1542/peds.2017-0516).
They considered data from the state’s immunization registry, simply counting seasonal immunization rates from 2012 to 2017. As a second assessment, they compared children who had previously received LAIV between Aug. 1 and Dec. 31, 2015, and children who received IIV during the same period, to see which cohort was more likely to return for flu vaccination the following season.
“Overall, 53.1% of children in the study with previous LAIV and 56.4% with a previous IIV returned for an IIV during the 2016-2017 season,” they reported. Those rates showed that the cohort with past injected vaccine was only 1.05 times more likely to return than the cohort with past nasal spray vaccine (95% confidence interval, 1.04-1.06). The investigators also concluded that overall rates have undergone “minimal changes” in the past 5 years, and the effect of the committee’s recommendation additionally was considered to be minimal.
Mr. Robison and his associates said they had no relevant financial disclosures. The study was funded in part by the CDC’s grants to Oregon statefor immunization surveillance.
Oregon researchers studying the effect of not recommending intranasal live attenuated influenza vaccines (LAIV) in favor of injected influenza vaccines (IIV) for the 2016-2017 flu season found that the change in recommendation had a minimal impact on overall flu vaccination rates, but that patients who had been given injected flu vaccine previously were slightly more likely to return for it the following season.
Steve G. Robison, MPH, of the Immunization Program of the Oregon Health Authority in Salem, led the study to monitor the effects of the new recommendation in Oregon, where he and his coauthors noted that there is “a substantial vaccine-hesitant population” (Pediatrics. 2017 Oct 6. doi: 10.1542/peds.2017-0516).
They considered data from the state’s immunization registry, simply counting seasonal immunization rates from 2012 to 2017. As a second assessment, they compared children who had previously received LAIV between Aug. 1 and Dec. 31, 2015, and children who received IIV during the same period, to see which cohort was more likely to return for flu vaccination the following season.
“Overall, 53.1% of children in the study with previous LAIV and 56.4% with a previous IIV returned for an IIV during the 2016-2017 season,” they reported. Those rates showed that the cohort with past injected vaccine was only 1.05 times more likely to return than the cohort with past nasal spray vaccine (95% confidence interval, 1.04-1.06). The investigators also concluded that overall rates have undergone “minimal changes” in the past 5 years, and the effect of the committee’s recommendation additionally was considered to be minimal.
Mr. Robison and his associates said they had no relevant financial disclosures. The study was funded in part by the CDC’s grants to Oregon statefor immunization surveillance.
Oregon researchers studying the effect of not recommending intranasal live attenuated influenza vaccines (LAIV) in favor of injected influenza vaccines (IIV) for the 2016-2017 flu season found that the change in recommendation had a minimal impact on overall flu vaccination rates, but that patients who had been given injected flu vaccine previously were slightly more likely to return for it the following season.
Steve G. Robison, MPH, of the Immunization Program of the Oregon Health Authority in Salem, led the study to monitor the effects of the new recommendation in Oregon, where he and his coauthors noted that there is “a substantial vaccine-hesitant population” (Pediatrics. 2017 Oct 6. doi: 10.1542/peds.2017-0516).
They considered data from the state’s immunization registry, simply counting seasonal immunization rates from 2012 to 2017. As a second assessment, they compared children who had previously received LAIV between Aug. 1 and Dec. 31, 2015, and children who received IIV during the same period, to see which cohort was more likely to return for flu vaccination the following season.
“Overall, 53.1% of children in the study with previous LAIV and 56.4% with a previous IIV returned for an IIV during the 2016-2017 season,” they reported. Those rates showed that the cohort with past injected vaccine was only 1.05 times more likely to return than the cohort with past nasal spray vaccine (95% confidence interval, 1.04-1.06). The investigators also concluded that overall rates have undergone “minimal changes” in the past 5 years, and the effect of the committee’s recommendation additionally was considered to be minimal.
Mr. Robison and his associates said they had no relevant financial disclosures. The study was funded in part by the CDC’s grants to Oregon statefor immunization surveillance.
FROM PEDIATRICS
Key clinical point:
Major finding: 53.1% of children in the study with previous LAIV and 56.4% with a previous IIV returned for an IIV during the 2016-2017 season.
Data source: Data from Oregon’s immunization registry.
Disclosures: Mr. Robison and his associates said they had no relevant financial disclosures. The study was funded in part by the CDC’s grants to Oregon state for immunization surveillance.
FDA approves pembrolizumab for gastric and GEJ adenocarcinoma
The Food and Drug Administration has approved pembrolizumab (Keytruda) for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, in cases where tests confirm that the tumors contain programmed death–ligand 1 and where the disease is progressing on or after two or more prior lines of therapy.
Pembrolizumab has been approved in the United States since 2014 for the treatment of melanoma, with subsequent approvals for treatment of non–small-cell lung cancer, head and neck squamous cell carcinoma, Hodgkin lymphoma, and several other advanced cancers.
The approval comes on the basis of the nonrandomized, open label KEYNOTE-059 trial, which enrolled 259 patients with gastric or GEJ adenocarcinoma that progressed on at least two prior systemic treatments for advanced disease. Of the enrollees, 143 patients had tumors with a PD-L1 Combined Positive Score of 1 or greater. The primary trial outcome, the objective response rate for these 143 patients, was 13.3% (95% confidence interval; 8.2-20), with a complete response rate of 1.4% and a partial response rate of 11.9%. The duration of response ranged from at least 2.8 months to at least 19.4 months.
Continued approval for the new indication will depend upon further demonstration of a clinical benefit in confirmatory trials.
The Food and Drug Administration has approved pembrolizumab (Keytruda) for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, in cases where tests confirm that the tumors contain programmed death–ligand 1 and where the disease is progressing on or after two or more prior lines of therapy.
Pembrolizumab has been approved in the United States since 2014 for the treatment of melanoma, with subsequent approvals for treatment of non–small-cell lung cancer, head and neck squamous cell carcinoma, Hodgkin lymphoma, and several other advanced cancers.
The approval comes on the basis of the nonrandomized, open label KEYNOTE-059 trial, which enrolled 259 patients with gastric or GEJ adenocarcinoma that progressed on at least two prior systemic treatments for advanced disease. Of the enrollees, 143 patients had tumors with a PD-L1 Combined Positive Score of 1 or greater. The primary trial outcome, the objective response rate for these 143 patients, was 13.3% (95% confidence interval; 8.2-20), with a complete response rate of 1.4% and a partial response rate of 11.9%. The duration of response ranged from at least 2.8 months to at least 19.4 months.
Continued approval for the new indication will depend upon further demonstration of a clinical benefit in confirmatory trials.
The Food and Drug Administration has approved pembrolizumab (Keytruda) for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma, in cases where tests confirm that the tumors contain programmed death–ligand 1 and where the disease is progressing on or after two or more prior lines of therapy.
Pembrolizumab has been approved in the United States since 2014 for the treatment of melanoma, with subsequent approvals for treatment of non–small-cell lung cancer, head and neck squamous cell carcinoma, Hodgkin lymphoma, and several other advanced cancers.
The approval comes on the basis of the nonrandomized, open label KEYNOTE-059 trial, which enrolled 259 patients with gastric or GEJ adenocarcinoma that progressed on at least two prior systemic treatments for advanced disease. Of the enrollees, 143 patients had tumors with a PD-L1 Combined Positive Score of 1 or greater. The primary trial outcome, the objective response rate for these 143 patients, was 13.3% (95% confidence interval; 8.2-20), with a complete response rate of 1.4% and a partial response rate of 11.9%. The duration of response ranged from at least 2.8 months to at least 19.4 months.
Continued approval for the new indication will depend upon further demonstration of a clinical benefit in confirmatory trials.
Sharing drug paraphernalia alone didn’t transmit HCV
nevertheless, according to researchers at Yale University, New Haven, Conn.
That makes sharing paraphernalia a “surrogate” for HCV transmission “resulting from sharing drugs,” the investigators said, but it should not be a primary focus of harm-reduction and education programs.
“Water was introduced into the barrel of a contaminated ‘input’ syringe and expelled into a ‘cooker,’ and the water was drawn up into a ‘receptive’ syringe through a cotton filter,” the study authors explained. “The ‘input’ syringe, ‘cooker,’ and filter were rinsed with tissue culture medium and introduced into the microculture assay. The water drawn into the second syringe was combined with an equal volume of double-strength medium and introduced into the microculture assay” (J Infect Dis. 2017. doi: 10.1093/infdis/jix427).
The researchers tested syringes (with fixed or detachable needles), cookers, and filters (single or pooled). They were significantly more likely to recover HCV from detachable-needle syringes than from fixed-needle syringes. In the input syringes, they recovered no HCV from 70 fixed-needle syringes while they did recover HCV from 96 of 130 (73.8%) detachable-needle syringes. HCV passed to both types of syringes in the experiment’s receptive syringes but at a much higher rate for those with detachable needles than for those with fixed needles (93.8% vs. 45.7%, respectively).
No HCV was recovered from any of the cookers, regardless of syringe type. Some was recovered from filters, at higher rates with detachable needles than with fixed (27.1% vs. 1.4%).
“Money spent on ‘cookers’ and filters would be better spent on giving away more syringes,” Dr. Heimer and his coauthors concluded. “Because HCV and HIV transmission are more likely if the syringe has a detachable rather than a fixed needle, efforts should focus on providing more syringes with fixed needles.”
nevertheless, according to researchers at Yale University, New Haven, Conn.
That makes sharing paraphernalia a “surrogate” for HCV transmission “resulting from sharing drugs,” the investigators said, but it should not be a primary focus of harm-reduction and education programs.
“Water was introduced into the barrel of a contaminated ‘input’ syringe and expelled into a ‘cooker,’ and the water was drawn up into a ‘receptive’ syringe through a cotton filter,” the study authors explained. “The ‘input’ syringe, ‘cooker,’ and filter were rinsed with tissue culture medium and introduced into the microculture assay. The water drawn into the second syringe was combined with an equal volume of double-strength medium and introduced into the microculture assay” (J Infect Dis. 2017. doi: 10.1093/infdis/jix427).
The researchers tested syringes (with fixed or detachable needles), cookers, and filters (single or pooled). They were significantly more likely to recover HCV from detachable-needle syringes than from fixed-needle syringes. In the input syringes, they recovered no HCV from 70 fixed-needle syringes while they did recover HCV from 96 of 130 (73.8%) detachable-needle syringes. HCV passed to both types of syringes in the experiment’s receptive syringes but at a much higher rate for those with detachable needles than for those with fixed needles (93.8% vs. 45.7%, respectively).
No HCV was recovered from any of the cookers, regardless of syringe type. Some was recovered from filters, at higher rates with detachable needles than with fixed (27.1% vs. 1.4%).
“Money spent on ‘cookers’ and filters would be better spent on giving away more syringes,” Dr. Heimer and his coauthors concluded. “Because HCV and HIV transmission are more likely if the syringe has a detachable rather than a fixed needle, efforts should focus on providing more syringes with fixed needles.”
nevertheless, according to researchers at Yale University, New Haven, Conn.
That makes sharing paraphernalia a “surrogate” for HCV transmission “resulting from sharing drugs,” the investigators said, but it should not be a primary focus of harm-reduction and education programs.
“Water was introduced into the barrel of a contaminated ‘input’ syringe and expelled into a ‘cooker,’ and the water was drawn up into a ‘receptive’ syringe through a cotton filter,” the study authors explained. “The ‘input’ syringe, ‘cooker,’ and filter were rinsed with tissue culture medium and introduced into the microculture assay. The water drawn into the second syringe was combined with an equal volume of double-strength medium and introduced into the microculture assay” (J Infect Dis. 2017. doi: 10.1093/infdis/jix427).
The researchers tested syringes (with fixed or detachable needles), cookers, and filters (single or pooled). They were significantly more likely to recover HCV from detachable-needle syringes than from fixed-needle syringes. In the input syringes, they recovered no HCV from 70 fixed-needle syringes while they did recover HCV from 96 of 130 (73.8%) detachable-needle syringes. HCV passed to both types of syringes in the experiment’s receptive syringes but at a much higher rate for those with detachable needles than for those with fixed needles (93.8% vs. 45.7%, respectively).
No HCV was recovered from any of the cookers, regardless of syringe type. Some was recovered from filters, at higher rates with detachable needles than with fixed (27.1% vs. 1.4%).
“Money spent on ‘cookers’ and filters would be better spent on giving away more syringes,” Dr. Heimer and his coauthors concluded. “Because HCV and HIV transmission are more likely if the syringe has a detachable rather than a fixed needle, efforts should focus on providing more syringes with fixed needles.”
FROM THE JOURNAL OF INFECTIOUS DISEASES