A potential new treatment for bullous pemphigoid (BP) is on the horizon as the U.S. Food and Drug Administration (FDA) grants priority review to Dupixent’s (dupilumab) supplemental biologics license application (sBLA). This decision marks a significant milestone in addressing this chronic, debilitating, and relapsing skin disease that affects thousands of Americans.
The priority review designation was granted based on positive results from a pivotal clinical trial. The study, which included 106 adults with moderate-to-severe BP, found that patients treated with Dupixent were five times more likely to achieve sustained disease remission compared to placebo. Sustained remission was defined as:
- Complete clinical remission with successful tapering off oral corticosteroids (OCS) by week 16
- Staying off OCS for at least 20 weeks while being treated solely with Dupixent
- No relapse or need for rescue therapy during the 36-week treatment period
Additionally, study results showed that Dupixent significantly reduced disease severity, itch, and reliance on OCS compared to placebo, offering a much-needed alternative to current treatment options.
Commonly reported adverse events (observed in at least three patients) included peripheral edema, arthralgia, back pain, blurred vision, hypertension, asthma, conjunctivitis, constipation, upper respiratory tract infections, limb injury, and insomnia.
This priority review brings hope to thousands of BP patients who currently face limited treatment options. If approved, Dupixent would become the first and only targeted medicine for BP in the United States.
The FDA’s decision is expected by June 20, 2025.
Source:
- Press Release: Dupixent sBLA accepted for FDA priority review for the targeted treatment of bullous pemphigoid. [Press release]. https://www.sanofi.com/en/media-room/press-releases/2025/2025-02-18-06-00-00-3027482
