Therapy Areas: Inflammatory Diseases
Regeneron Pharmaceuticals reveals positive CHMP opinion for EU Dupixent extension to include children aged 6 to 11 years with severe atopic dermatitis
19 October 2020 -

United States-based Regeneron Pharmaceuticals Inc (NASDAQ: REGN) and France-based Sanofi have received a positive opinion for Dupixent (dupilumab)from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), for the product's approval in the European Union to be extended to include children aged 6 to 11 years with severe atopic dermatitis who are candidates for systemic therapy, it was reported on Friday.

The product is currently the first and only biologic approved for the treatment of uncontrolled moderate-to-severe atopic dermatitis for patients 12 years of age and older in the EU and 6 years of age and older in the United States. It is also approved in the European Union for certain patients with severe asthma and severe chronic rhinosinusitis with nasal polyps (CRSwNP), two other type two inflammatory diseases.

The positive CHMP opinion is supported by data that include pivotal Phase 3 results on the efficacy and safety of Dupixent combined with topical corticosteroids (TCS) in children aged 6 to 11 years with severe atopic dermatitis that is uncontrolled on topical prescription therapies.

The European Commission is likely to announce a final decision on the Dupixent application in the coming months.

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