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Tralokinumab earns EU recommendation to expand age range for atopic dermatitis to include adolescents
Tralokinumab has received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use to extend use to adolescents aged 12 years and older with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy, according to a statement from the manufacturer.
The positive CHMP opinion, issued on Sept. 15, recommends extending the use of tralokinumab (Adtralza), an interleukin-13 antagonist, to adolescents aged 12-17 years in the EU. The positive opinion recommends an initial dose of 600 mg administered subcutaneously followed by 300 mg every other week, the dosing recommended for adults.
In December 2021, tralokinumab was approved for adults with moderate to severe AD in the United States, where it is marketed as Adbry. It is also approved for adults in the EU, Great Britain, Canada, the United Arab Emirates, and Switzerland. It is not currently approved for treatment of adolescents in any country, according to the LEO Pharma statement.
A regulatory filing with the U.S. Food and Drug Administration is in progress, the company said, and an additional study of tralokinumab for individuals aged 12 years and older is underway, according to the manufacturer.
The CHMP opinion was supported by data from a phase 3 study (ECZTRA 6) that assessed safety and efficacy of 150-mg or 300-mg doses of tralokinumab, compared with placebo in adolescents with moderate-to-severe AD, the company statement said. The primary outcomes were an Investigator Global Assessment score of clear or almost clear skin (IGA 0/1) and an improvement of at least a 75% on the Eczema Area and Severity Index score (EASI-75). In the study, presented as a poster at a meeting in October 2021, a total of 195 adolescents aged 12-17 with moderate to severe AD who were candidates for systemic therapy were randomly assigned to tralokinumab and 94 to placebo.
At 16 weeks, 21.4% and 17.5% of patients who received 150 mg and 300 mg, respectively, of tralokinumab had IGA scores of 0 or 1, compared with 4.3% of those on placebo (P < .001, P = .002, respectively vs. placebo). In addition, 28.6% and 27.8% of the 150-mg and 300-mg tralokinumab groups, respectively, achieved EASI-75, compared with 6.4% of placebo patients (P < .001, P = .001, respectively, compared with placebo).
Adverse events were similar between the groups, and most were mild or moderate; overall safety profiles were similar to those seen in adult patients.
The European Commission will review the positive opinion and make a final decision.
The research was supported by LEO Pharma.
A version of this article first appeared on Medscape.com.
Tralokinumab has received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use to extend use to adolescents aged 12 years and older with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy, according to a statement from the manufacturer.
The positive CHMP opinion, issued on Sept. 15, recommends extending the use of tralokinumab (Adtralza), an interleukin-13 antagonist, to adolescents aged 12-17 years in the EU. The positive opinion recommends an initial dose of 600 mg administered subcutaneously followed by 300 mg every other week, the dosing recommended for adults.
In December 2021, tralokinumab was approved for adults with moderate to severe AD in the United States, where it is marketed as Adbry. It is also approved for adults in the EU, Great Britain, Canada, the United Arab Emirates, and Switzerland. It is not currently approved for treatment of adolescents in any country, according to the LEO Pharma statement.
A regulatory filing with the U.S. Food and Drug Administration is in progress, the company said, and an additional study of tralokinumab for individuals aged 12 years and older is underway, according to the manufacturer.
The CHMP opinion was supported by data from a phase 3 study (ECZTRA 6) that assessed safety and efficacy of 150-mg or 300-mg doses of tralokinumab, compared with placebo in adolescents with moderate-to-severe AD, the company statement said. The primary outcomes were an Investigator Global Assessment score of clear or almost clear skin (IGA 0/1) and an improvement of at least a 75% on the Eczema Area and Severity Index score (EASI-75). In the study, presented as a poster at a meeting in October 2021, a total of 195 adolescents aged 12-17 with moderate to severe AD who were candidates for systemic therapy were randomly assigned to tralokinumab and 94 to placebo.
At 16 weeks, 21.4% and 17.5% of patients who received 150 mg and 300 mg, respectively, of tralokinumab had IGA scores of 0 or 1, compared with 4.3% of those on placebo (P < .001, P = .002, respectively vs. placebo). In addition, 28.6% and 27.8% of the 150-mg and 300-mg tralokinumab groups, respectively, achieved EASI-75, compared with 6.4% of placebo patients (P < .001, P = .001, respectively, compared with placebo).
Adverse events were similar between the groups, and most were mild or moderate; overall safety profiles were similar to those seen in adult patients.
The European Commission will review the positive opinion and make a final decision.
The research was supported by LEO Pharma.
A version of this article first appeared on Medscape.com.
Tralokinumab has received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use to extend use to adolescents aged 12 years and older with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy, according to a statement from the manufacturer.
The positive CHMP opinion, issued on Sept. 15, recommends extending the use of tralokinumab (Adtralza), an interleukin-13 antagonist, to adolescents aged 12-17 years in the EU. The positive opinion recommends an initial dose of 600 mg administered subcutaneously followed by 300 mg every other week, the dosing recommended for adults.
In December 2021, tralokinumab was approved for adults with moderate to severe AD in the United States, where it is marketed as Adbry. It is also approved for adults in the EU, Great Britain, Canada, the United Arab Emirates, and Switzerland. It is not currently approved for treatment of adolescents in any country, according to the LEO Pharma statement.
A regulatory filing with the U.S. Food and Drug Administration is in progress, the company said, and an additional study of tralokinumab for individuals aged 12 years and older is underway, according to the manufacturer.
The CHMP opinion was supported by data from a phase 3 study (ECZTRA 6) that assessed safety and efficacy of 150-mg or 300-mg doses of tralokinumab, compared with placebo in adolescents with moderate-to-severe AD, the company statement said. The primary outcomes were an Investigator Global Assessment score of clear or almost clear skin (IGA 0/1) and an improvement of at least a 75% on the Eczema Area and Severity Index score (EASI-75). In the study, presented as a poster at a meeting in October 2021, a total of 195 adolescents aged 12-17 with moderate to severe AD who were candidates for systemic therapy were randomly assigned to tralokinumab and 94 to placebo.
At 16 weeks, 21.4% and 17.5% of patients who received 150 mg and 300 mg, respectively, of tralokinumab had IGA scores of 0 or 1, compared with 4.3% of those on placebo (P < .001, P = .002, respectively vs. placebo). In addition, 28.6% and 27.8% of the 150-mg and 300-mg tralokinumab groups, respectively, achieved EASI-75, compared with 6.4% of placebo patients (P < .001, P = .001, respectively, compared with placebo).
Adverse events were similar between the groups, and most were mild or moderate; overall safety profiles were similar to those seen in adult patients.
The European Commission will review the positive opinion and make a final decision.
The research was supported by LEO Pharma.
A version of this article first appeared on Medscape.com.
New crayons reflect the global palette of skin tones
After more than 8 months of development,
“With the world growing more diverse than ever before, Crayola hopes our new Colors of the World crayons will increase representation and foster a greater sense of belonging and acceptance,” CEO Rich Wuerthele said in a written statement.
The company partnered with a cosmetic industry foundation-color expert to create “colors that step down from light to deep shades across rose, almond, and golden undertones, resulting in a 24 global shade palette that authentically reflects the full spectrum of human complexions,” according to Crayola’s statement. The 24- and 32-count Colors of the World packs will start reaching stores in July. The pack of 32 crayons includes the 24 skin colors along with 4 hair and 4 eye colors.
After more than 8 months of development,
“With the world growing more diverse than ever before, Crayola hopes our new Colors of the World crayons will increase representation and foster a greater sense of belonging and acceptance,” CEO Rich Wuerthele said in a written statement.
The company partnered with a cosmetic industry foundation-color expert to create “colors that step down from light to deep shades across rose, almond, and golden undertones, resulting in a 24 global shade palette that authentically reflects the full spectrum of human complexions,” according to Crayola’s statement. The 24- and 32-count Colors of the World packs will start reaching stores in July. The pack of 32 crayons includes the 24 skin colors along with 4 hair and 4 eye colors.
After more than 8 months of development,
“With the world growing more diverse than ever before, Crayola hopes our new Colors of the World crayons will increase representation and foster a greater sense of belonging and acceptance,” CEO Rich Wuerthele said in a written statement.
The company partnered with a cosmetic industry foundation-color expert to create “colors that step down from light to deep shades across rose, almond, and golden undertones, resulting in a 24 global shade palette that authentically reflects the full spectrum of human complexions,” according to Crayola’s statement. The 24- and 32-count Colors of the World packs will start reaching stores in July. The pack of 32 crayons includes the 24 skin colors along with 4 hair and 4 eye colors.
‘Recognizing Redness’
The National Rosacea Society has released a booklet for patients called “Recognizing Redness” to help them assess their complexion before and after a rosacea flare or treatment, as well as better understand their disease, according to a release from the society. The booklet contains a redness register that lets patients compare their skin’s natural redness with that of areas affected by their rosacea; it also contains information about the disease, its diagnosis, and common triggers. The booklet is freely available on the society’s website www.rosacea.org/patients/recognizing-redness-patient-guide-rosacea. It can also be provided in bulk to health care providers and acquired directly by writing the National Rosacea Society, 196 James Street, Barrington, IL 60010, calling the society toll-free at 1-888-NO-BLUSH, or via e-mail at rosaceas@aol.com. The new booklet was made possible by support from Aclaris.
The National Rosacea Society has released a booklet for patients called “Recognizing Redness” to help them assess their complexion before and after a rosacea flare or treatment, as well as better understand their disease, according to a release from the society. The booklet contains a redness register that lets patients compare their skin’s natural redness with that of areas affected by their rosacea; it also contains information about the disease, its diagnosis, and common triggers. The booklet is freely available on the society’s website www.rosacea.org/patients/recognizing-redness-patient-guide-rosacea. It can also be provided in bulk to health care providers and acquired directly by writing the National Rosacea Society, 196 James Street, Barrington, IL 60010, calling the society toll-free at 1-888-NO-BLUSH, or via e-mail at rosaceas@aol.com. The new booklet was made possible by support from Aclaris.
The National Rosacea Society has released a booklet for patients called “Recognizing Redness” to help them assess their complexion before and after a rosacea flare or treatment, as well as better understand their disease, according to a release from the society. The booklet contains a redness register that lets patients compare their skin’s natural redness with that of areas affected by their rosacea; it also contains information about the disease, its diagnosis, and common triggers. The booklet is freely available on the society’s website www.rosacea.org/patients/recognizing-redness-patient-guide-rosacea. It can also be provided in bulk to health care providers and acquired directly by writing the National Rosacea Society, 196 James Street, Barrington, IL 60010, calling the society toll-free at 1-888-NO-BLUSH, or via e-mail at rosaceas@aol.com. The new booklet was made possible by support from Aclaris.