In June, officials with Sanofi and Regeneron announced that dupilumab (Dupixent) had been greenlit for the treatment of adult patients living with bullous pemphigoid (BP).1
The FDA approval included insights from data from the ADEPT (NCT04206553) phase 2/3 study, which evaluated the efficacy and safety of dupilumab compared with placebo in adults with moderate-to-severe BP. Patients were randomly assigned to receive either Dupixent 300 mg (n=53) or placebo (n=53) added to standard-of-care oral corticosteroids (OCS).
During the FDA review, the analyses were updated; the FDA-approved results at 36 weeks in the label for dupilumab compared with placebo are:
- 18.3% of patients experienced sustained disease remission compared with 6.1% (12.2% difference; 95% confidence interval, –0.8%-26.1%), the primary end point
- 38.3% of patients achieved clinically meaningful itch reduction compared with 10.5%
- Median cumulative OCS dose was 2.8g compared with 4.1g
BP is a chronic, debilitating, and relapsing rare skin disease affecting approximately 27,000 adults in the United States whose disease is uncontrolled by systemic corticosteroids.
Reference
- Sanofi. Dupixent approved in the US as the only targeted medicine to treat patients with bullous pemphigoid [press release]. June 20, 2025. Accessed July 8, 2025. www.sanofi.com/en/media-room/press-releases/2025/2025-06-20-05-00-00-3102518