Dupixent continues to grow with new US indication

The US Food and Drug Administration has approved a label extension for Dupixent (dupilumab), from Sanofi (Euronext: SAN), to include treatment of children aged six to 11 with moderate-to-severe atopic dermatitis (AD).

The approval, which covers children who cannot be successfully treated with topical prescription therapies, makes Dupixent the only biologic approved for this patient population.

The decision is based on results from a Phase III program which compared the efficacy and safety of Dupixent combined with topical corticosteroids (TCS), with TCS alone.