The US Food and Drug Administration (FDA) has accepted for priority review Regeneron and 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

Priority review is granted to regulatory applications seeking approval for therapies that have the potential to provide significant improvements in the treatment, diagnosis, or prevention of serious conditions. Dupixent was previously granted orphan drug designation by the FDA for BP.

The sBLA is supported by data from a pivotal study 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 (OCS) taper by week 16 (off OCS treatment and only treated with Dupixent for at least 20 weeks) without relapse and no rescue therapy use during the 36-week treatment period. The study also showed that Dupixent significantly reduced disease severity, itch, and use of OCS compared to placebo.

Adverse events more commonly observed with Dupixent (in at least 3 patients) compared to placebo included peripheral edema, arthralgia, back pain, blurred vision, hypertension, asthma, conjunctivitis, constipation, upper respiratory tract infection, limb injury, and insomnia.

The safety and efficacy of Dupixent in BP are currently under clinical assessment and have not been evaluated by any regulatory authority.