FDA accepts Dupixent sBLA for priority review in bullous pemphigoid

The US Food and Drug Administration (FDA) has accepted for priority review the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat adults with bullous pemphigoid (BP).

If approved, French pharma major Sanofi’s (Euronext: SAN) mega blockbuster inflammatory disease drug Dupixent would be the first and only targeted medicine to treat BP in the USA. The FDA decision expected by June 20, 2025, the company noted.

Dupixent, developed under a collaboration with Regeneron (Nasdaq: REGN) and posting full-year 2024 sales of around 13 billion euros ($13.7 billion), was previously granted Orphan Drug designation by the FDA for BP.