Regeneron (REGN.US) and Sanofi (SNY.US) are expected to add new indications for their blockbuster anti-inflammatory drugs in the middle of the year.

Recently, Regeneron (REGN.US) and Sanofi (SNY.US) announced positive results from the key phase 2/3 clinical trial ADEPT at the 2025 American Academy of Dermatology (AAD) Annual Meeting. The trial evaluated the efficacy and safety of the blockbuster therapy Dupixent (dupilumab) in treating adult patients with severe bullous pemphigoid (BP). ADEPT trial met all primary and key secondary endpoints, with patients treated with Dupixent achieving a five-fold increase in the proportion of sustained remission compared to the placebo group. The supplemental biologics license application (sBLA) for Dupixent in the treatment of BP has received priority review designation from the FDA and is expected to be approved by mid-year. Dupixent is a fully humanized monoclonal antibody that inhibits the interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling pathways. It has regulatory approval for one or more indications in more than 60 countries and regions worldwide, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, nodular prurigo, chronic spontaneous urticaria, and chronic obstructive pulmonary disease. Over one million patients globally are currently being treated with Dupixent.