On June 20, 2025, the FDA approved Dupixent (dupilumab), developed by Sanofi and Regeneron, as the first and only targeted therapy for adult patients with bullous pemphigoid (BP) in the US123.
Bullous pemphigoid is a rare, chronic autoimmune skin disease affecting approximately 27,000 adults in the US, mainly those over 70, characterized by painful blisters, lesions, and severe itch. Current standard treatments involve systemic corticosteroids, which have significant side effects, especially in older patients3.
Dupixent targets type 2 inflammation by inhibiting IL-4 and IL-13 signaling pathways and demonstrated significant efficacy:
in the pivotal ADEPT trial, 18.3% of Dupixent-treated patients achieved sustained remission at 36 weeks—over three times the rate seen with placebo—and reduced steroid use by 31%3.
The FDA granted priority review to Dupixent for BP, recognizing its potential to provide a significant improvement over existing therapies. It previously received orphan drug designation for this indication145.
This marks Dupixent’s eighth FDA-approved indication, spanning several diseases driven by type 2 inflammation, and reinforces its established safety profile for a broad range of ages and conditions1.
Additional regulatory reviews for Dupixent as a treatment for BP are underway in the EU, Japan, and China1.
Sources:
1. https://www.sanofi.com/en/media-room/press-releases/2025/2025-06-20-05-00-00-3102518
2. https://www.hcplive.com/view/fda-approves-dupilumab-dupixent-for-bullous-pemphigoid-in-adult-patients
3. https://www.ainvest.com/news/dupixent-bp-approval-signals-era-sanofi-regeneron-type-2-inflammation-dominance-2506/
4. https://www.sanofi.com/en/media-room/press-releases/2025/2025-03-08-18-00-00-3039375
5. https://www.sanofi.com/en/media-room/press-releases/2025/2025-02-18-06-00-00-3027482