Sanofi wins EU approval for Dupixent for atopic dermatitis in children
Dupixent is the only systemic medicine approved in the EU to treat these patients.;
Paris: Pharma major, Sanofi, has recently announced that the European Commission (EC) has extended the marketing authorization for Dupixent (dupilumab) in the European Union (EU) to include children 6 to 11 years of age with severe atopic dermatitis who are candidates for systemic therapy.
Dupixent is the only systemic medicine approved in the EU to treat these patients.
"As the parent of a child with atopic dermatitis, and someone who works with families impacted by this condition daily, I've seen first-hand the enormous physical and mental health burden of this disease, and the toll it can take on the entire family," said Korey Capozza, MPH, Founder and Executive Director of Global Parents for Eczema Research (GPER). "Young children with severe atopic dermatitis currently have few treatment choices and significant unmet needs. We welcome the addition of new medicines for these underserved patients."
Atopic dermatitis is a chronic inflammatory disease of the skin that can be debilitating, and severe disease can significantly impact many aspects of life for both children and their families. The current standard of care for children with severe atopic dermatitis in Europe is limited to topical treatments, leaving those with poorly controlled disease to cope with intense, unrelenting itch and skin lesions that can cover much of the body, resulting in skin cracking, redness or darkening, crusting and oozing. In addition, uncontrolled severe atopic dermatitis can have a substantial emotional and psychosocial impact, causing sleep disturbance, symptoms of anxiety and depression and feelings of isolation in children.
- Improved disease extent and severity: 82% and 80% average improvement from baseline with Dupixent every four and two weeks, respectively, compared to 49% and 48% for placebo. In addition, 70% and 75% of Dupixent patients achieved at least a 75% improvement in the four-week and two-week treatment groups, respectively, compared to 17% and 26% for placebo.
- Skin clearance: 33% and 39% of patients achieved clear or almost clear skin with Dupixent every four and two weeks respectively, compared to 11% and 10% for placebo.
- Reduced itch: 51% and 61% of patients achieved clinically significant reduction with Dupixent every four and two weeks, respectively, compared to 12% and 13% for placebo. A significantly greater proportion of Dupixent patients achieved improvement in itch as early as four weeks.
- Improved health-related quality of life (HR-QoL): 77% and 81% of patients experienced clinically meaningful improvement in patient-reported HR-QoLwith Dupixent every four and two weeks, respectively, compared to 39% and 36% for placebo. Dupixent patients also experienced improvements in additional HR-QoL measures assessing disease severity and patient-reported measures such as itch and sleep.
The safety profile of Dupixent in children 6-11 years of age followed through week 52, based on an open-label extension trial, was similar to the safety profile observed at week 16 and consistent with the safety profile seen in adults and adolescents with atopic dermatitis. Overall rates of adverse events (AEs) were 65% and 61% for Dupixent every four and two weeks respectively, and 73% and 75% for placebo. AEs that were more commonly observed with Dupixent included upper respiratory tract infections (11% and 9% for Dupixent every four and two weeks, 10% and 12% for placebo), injection site reactions (10% and 14% for Dupixent every four and two weeks, 6% and 5% for placebo), nasopharyngitis (13% and 3% for Dupixent every four and two weeks, 7% and 10% for placebo), conjunctivitis (7% and 9% for Dupixent every four and two weeks, 4% and 5% for placebo), and fever (3% for both Dupixent groups, 2% and 0% for placebo). Additional prespecified AEs included skin infections (6% and 9% for Dupixent every four and two weeks, 13% for both placebo groups), and herpes viral infections (2% for both Dupixent groups, 5% for both placebo groups).
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