Policy & Regulation
Sanofi and Regeneron's Dupilumab recommended for expanded EU approval
27 January 2023 -

French healthcare company Sanofi SA (Euronext Paris:SAN) (Nasdaq:SNY) said on Friday that Dupixent (dupilumab) has been recommended by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for expanded approval in the European Union to treat children as young as six months old with severe atopic dermatitis.

Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. It is being jointly developed by Sanofi and Regeneron Pharmaceuticals Inc (Nasdaq:REGN) under a global collaboration agreement.

The CHMP recommendation is based on a Phase 3 trial in children aged six months to five years, showing that Dupixent improved skin clearance, reduced overall disease severity and improved health-related quality of life.

Dupixent has received regulatory approvals in countries around the world for use in certain patients with atopic dermatitis, prurigo nodularis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP) or eosinophilic esophagitis (EoE) in different age populations. Dupixent is currently approved for one or more of these indications in over 60 countries, including in Europe, the United States and Japan.