The US Food and Drug Administration (FDA) has accepted for priority review Sanofi’s supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat adults with bullous pemphigoid (BP), a chronic, debilitating, and relapsing skin disease with underlying type-2 inflammation that typically occurs in an elderly population

If approved, Dupixent would be the first and only targeted medicine to treat BP in the U.S.; FDA decision expected by June 20, 2025Priority

Regeneron and Sanofi on Tuesday said the speedy FDA review is based on study results showing significant improvements in sustained disease remission with Dupixent compared with placebo. The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease,