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Dupixent® (dupilumab) Recommended for Expanded EU Approval by the CHMP to Treat Children as Young as Six Months Old with Severe Atopic Dermatitis
If approved, Dupixent would be the first and only targeted medicine in the EU for these young children Recommendation based on a Phase 3 trial in children 6
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"If approved, Dupixent would be the first and only targeted medicine in the EU for these young children Recommendation based on a Phase 3 trial in children 6 months to 5 years old showing Dupixent improved skin clearance, reduced overall disease severity and improved health-related quality of life In Europe, about 80,000 children aged 6 months to 5 years with uncontrolled severe atopic dermatitis are candidates for systemic therapy TARRYTOWN, N.Y. and PARIS, Jan. 27, 2023 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Dupixent® (dupilumab), recommending expanded approval in the European Union (EU) to treat severe atopic dermatitis in children 6 months to 5 years old who are candidates for systemic therapy. The European Commission is expected to announce a final decision on the Dupixent application in the coming months. In June 2022, Dupixent was approved by the U.S. Food and Drug Administration for children in this age group. Atopic dermatitis is a chronic type 2 inflammatory skin disease. Between 85% and 90% of patients first develop symptoms before 5 years of age, which can often continue through adulthood. Symptoms include intense, persistent itch and skin lesions that cover much of the body, resulting in skin dryness, cracking, pain, redness or darkening, crusting and oozing, which can increase the risk of skin infection. Severe atopic dermatitis may also significantly impact the quality of life of young children and their caregivers. Current treatment options in this age group are primarily topical corticosteroids (TCS), which can be associated with safety risks and may impair growth when used long-term. The positive CHMP opinion is supported by data from a Phase 3 trial in children 6 months to 5 years of age recently published in The Lancet, which met all primary and secondary endpoints. At 16 weeks, Dupixent plus low-potency TCS improved skin clearance and reduced overall disease severity compared to TCS alone (the placebo arm). Dupixent patients also experienced reduced itch and skin pain as well as improved sleep quality and health-related quality of life compared to placebo. Long-term data further showed a sustained improvement in these disease measures ...