The U.S. Food and Drug Administration (FDA) has approved Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi’s (NASDAQ:SNY) lead drug candidate Dupixent (dupilumab) for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis.
The regulatory approval was supported by data readout from Phase 3 trial evaluating Dupixent, that met both primary and all secondary endpoints.
George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer, commented : “Young children with moderate-to-severe atopic dermatitis are a significantly underserved population of patients, who spend vulnerable years of their lives suffering through the relentless and far-reaching effects of this chronic disease. Dupixent has changed the atopic dermatitis treatment paradigm, significantly clearing skin and reducing itch, by targeting an underlying cause of this disease without broadly suppressing the immune system.”
FDA evaluated Dupixent’s supplemental Biologics License Applications (sBLA) under Priority Review, reserved for medicines that represent potentially significant improvements in efficacy or safety in treating serious conditions.
The company said that Dupixent is the first and only biologic medicine approved to treat moderate-to-severe atopic dermatitis from infancy through adulthood.
Regeneron Shares closed Tuesday’s trading session high at $613.98.
