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The first case of progressive multifocal leukoencephalopathy has occurred in a patient with multiple sclerosis treated with fingolimod, according to the Food and Drug Administration.
The patient was diagnosed with progressive multifocal leukoencephalopathy (PML), the rare, often fatal opportunistic demyelinating infection, after almost 8 months of treatment with fingolimod, the agency reported on Aug. 29.
Fingolimod is a sphingosine 1-phosphate receptor modulator that was approved in 2010 for treating relapsing forms of MS.
The patient had not been treated with natalizumab, the MS drug that is known to increase the risk of the brain infection, but did receive 1 month of treatment with interferon beta-1a and azathioprine prior to beginning treatment with fingolimod. Those drugs were stopped when treatment with fingolimod began. However, the patient was also treated with "multiple courses" of intravenous corticosteroids for several months before and during treatment with fingolimod, which is marketed by Novartis under the name Gilenya.
Treatment with fingolimod was stopped after the diagnosis of PML, made on the basis of clinical symptoms and detection of JC viral DNA in cerebrospinal fluid, according to the FDA statement, which does not say whether the patient survived. The case was reported in Europe.
PML is caused by the JC virus, a common virus that usually does not cause illness, but can cause PML in people who are immunocompromised or are taking medications with immunosuppressive effects.
After several PML cases were reported in patients with MS treated with natalizumab (Tysabri) months after it was approved for treating MS in 2004, it was taken off the market in 2005 and reintroduced in June 2006 with measures to address the risk of PML, including a restricted distribution program.
The FDA is working with Novartis to investigate this case and will make recommendations when the evaluation has been completed, the statement said. The FDA is advising patients not to stop treatment with fingolimod before discussing this with their health care professionals.
The precautions and warnings section of the fingolimod label includes a statement that the treatment causes a dose-dependent reduction in peripheral lymphocyte count, due to reversible sequestration of lymphocytes in lymphoid tissues, and the drug "may therefore increase the risk of infections, some serious in nature," but PML is not mentioned. The label also says that it has not been administered with antineoplastic, immunosuppressive, or immune modulating therapies used to treat MS and that use of fingolimod with any of these treatments "would be expected to increase the risk of immunosuppression."
Fingolimod was approved with a risk evaluation and mitigation strategy, addressing the serious risks associated with treatment, including bradyarrhythmia and atrioventricular block at the start of treatment, infections, macular edema, respiratory effects, hepatic effects, and fetal risk.
According to Novartis, about 71,000 patients worldwide have been treated with fingolimod.
The safety communication is available here. Serious adverse events associated with fingolimod should be reported to the FDA’s MedWatch program at 800-332-1088.
The first case of progressive multifocal leukoencephalopathy has occurred in a patient with multiple sclerosis treated with fingolimod, according to the Food and Drug Administration.
The patient was diagnosed with progressive multifocal leukoencephalopathy (PML), the rare, often fatal opportunistic demyelinating infection, after almost 8 months of treatment with fingolimod, the agency reported on Aug. 29.
Fingolimod is a sphingosine 1-phosphate receptor modulator that was approved in 2010 for treating relapsing forms of MS.
The patient had not been treated with natalizumab, the MS drug that is known to increase the risk of the brain infection, but did receive 1 month of treatment with interferon beta-1a and azathioprine prior to beginning treatment with fingolimod. Those drugs were stopped when treatment with fingolimod began. However, the patient was also treated with "multiple courses" of intravenous corticosteroids for several months before and during treatment with fingolimod, which is marketed by Novartis under the name Gilenya.
Treatment with fingolimod was stopped after the diagnosis of PML, made on the basis of clinical symptoms and detection of JC viral DNA in cerebrospinal fluid, according to the FDA statement, which does not say whether the patient survived. The case was reported in Europe.
PML is caused by the JC virus, a common virus that usually does not cause illness, but can cause PML in people who are immunocompromised or are taking medications with immunosuppressive effects.
After several PML cases were reported in patients with MS treated with natalizumab (Tysabri) months after it was approved for treating MS in 2004, it was taken off the market in 2005 and reintroduced in June 2006 with measures to address the risk of PML, including a restricted distribution program.
The FDA is working with Novartis to investigate this case and will make recommendations when the evaluation has been completed, the statement said. The FDA is advising patients not to stop treatment with fingolimod before discussing this with their health care professionals.
The precautions and warnings section of the fingolimod label includes a statement that the treatment causes a dose-dependent reduction in peripheral lymphocyte count, due to reversible sequestration of lymphocytes in lymphoid tissues, and the drug "may therefore increase the risk of infections, some serious in nature," but PML is not mentioned. The label also says that it has not been administered with antineoplastic, immunosuppressive, or immune modulating therapies used to treat MS and that use of fingolimod with any of these treatments "would be expected to increase the risk of immunosuppression."
Fingolimod was approved with a risk evaluation and mitigation strategy, addressing the serious risks associated with treatment, including bradyarrhythmia and atrioventricular block at the start of treatment, infections, macular edema, respiratory effects, hepatic effects, and fetal risk.
According to Novartis, about 71,000 patients worldwide have been treated with fingolimod.
The safety communication is available here. Serious adverse events associated with fingolimod should be reported to the FDA’s MedWatch program at 800-332-1088.
The first case of progressive multifocal leukoencephalopathy has occurred in a patient with multiple sclerosis treated with fingolimod, according to the Food and Drug Administration.
The patient was diagnosed with progressive multifocal leukoencephalopathy (PML), the rare, often fatal opportunistic demyelinating infection, after almost 8 months of treatment with fingolimod, the agency reported on Aug. 29.
Fingolimod is a sphingosine 1-phosphate receptor modulator that was approved in 2010 for treating relapsing forms of MS.
The patient had not been treated with natalizumab, the MS drug that is known to increase the risk of the brain infection, but did receive 1 month of treatment with interferon beta-1a and azathioprine prior to beginning treatment with fingolimod. Those drugs were stopped when treatment with fingolimod began. However, the patient was also treated with "multiple courses" of intravenous corticosteroids for several months before and during treatment with fingolimod, which is marketed by Novartis under the name Gilenya.
Treatment with fingolimod was stopped after the diagnosis of PML, made on the basis of clinical symptoms and detection of JC viral DNA in cerebrospinal fluid, according to the FDA statement, which does not say whether the patient survived. The case was reported in Europe.
PML is caused by the JC virus, a common virus that usually does not cause illness, but can cause PML in people who are immunocompromised or are taking medications with immunosuppressive effects.
After several PML cases were reported in patients with MS treated with natalizumab (Tysabri) months after it was approved for treating MS in 2004, it was taken off the market in 2005 and reintroduced in June 2006 with measures to address the risk of PML, including a restricted distribution program.
The FDA is working with Novartis to investigate this case and will make recommendations when the evaluation has been completed, the statement said. The FDA is advising patients not to stop treatment with fingolimod before discussing this with their health care professionals.
The precautions and warnings section of the fingolimod label includes a statement that the treatment causes a dose-dependent reduction in peripheral lymphocyte count, due to reversible sequestration of lymphocytes in lymphoid tissues, and the drug "may therefore increase the risk of infections, some serious in nature," but PML is not mentioned. The label also says that it has not been administered with antineoplastic, immunosuppressive, or immune modulating therapies used to treat MS and that use of fingolimod with any of these treatments "would be expected to increase the risk of immunosuppression."
Fingolimod was approved with a risk evaluation and mitigation strategy, addressing the serious risks associated with treatment, including bradyarrhythmia and atrioventricular block at the start of treatment, infections, macular edema, respiratory effects, hepatic effects, and fetal risk.
According to Novartis, about 71,000 patients worldwide have been treated with fingolimod.
The safety communication is available here. Serious adverse events associated with fingolimod should be reported to the FDA’s MedWatch program at 800-332-1088.
