Regeneron (REGN.US) and Sanofi (SNY.US) land FDA approval for blockbuster therapy.

The blockbuster therapy Dupixent (dupilumab), jointly developed by Regeneron (REGN.US) and Sanofi (SNY.US), has been approved by the US FDA for the treatment of Bullous Pemphigoid (BP) in adult patients. According to the press release, Dupixent is the first BP therapy to receive FDA approval. BP is a chronic and recurrent skin disease with underlying type 2 inflammation, which typically occurs in the elderly population. It is characterized by severe itching, blisters, redness, and painful lesions on the skin. Blisters and rashes may spread all over the body, leading to skin bleeding and crusting, making patients more prone to infection and affecting their daily lives. Analysis results showed that 18.3% of patients achieved sustained disease remission in the primary endpoint, compared to 6.1% in the placebo group (difference of 12.2%; 95% CI: -0.8% to 26.1%). Additionally, 38.3% of patients achieved clinically significant relief from itching, compared to 10.5% in the placebo group. Furthermore, the median cumulative oral corticosteroid dose in the Dupixent group was 2.8 grams, lower than the 4.1 grams in the placebo group.