Regeneron, Sanofi announce Dupixent sBLA accepted for priority review by FDA

Regeneron (REGN) and Sanofi (SNY) announced that the FDA has accepted for priority review the supplemental biologics license application for Dupixent to treat adults with bullous pemphigoid. The sBLA is supported by data from a trial evaluating the efficacy and safety of Dupixent in 106 adults with moderate-to-severe BP. The primary endpoint was met, with five times more Dupixent patients achieving sustained disease remission compared to those on placebo. Sustained disease remission was defined as complete clinical remission with completion of oral corticosteroids taper by week 16 without relapse and no rescue therapy use during the 36-week treatment period. The trial also showed that Dupixent significantly reduced disease severity, itch and use of OCS compared to placebo. Adverse events more commonly observed with Dupixent compared to placebo included peripheral edema, arthralgia, back pain, blurred vision, hypertension, asthma, conjunctivitis, constipation, upper respiratory tract infection, limb injury and insomnia.