FDA Approves Regeneron Sanofi Treatment For Rare Autoimmune Skin Disorder - Regeneron Pharmaceuticals (NASDAQ:REGN), Sanofi (NASDAQ:SNY)
- On June 20, 2025, the FDA granted approval for Dupixent to be used in the United States for managing bullous pemphigoid in adult individuals.
- This approval followed the pivotal ADEPT Phase 2/3 trial, where Dupixent demonstrated significant improvement in disease remission and symptom control in adults with moderate-to-severe BP.
- Bullous pemphigoid is an uncommon, long-lasting autoimmune condition that mainly impacts older adults, causing painful blisters, severe itching, skin inflammation, and an increased risk of infection, affecting about 27,000 people in the United States.
- In the ADEPT study, 18.3% of individuals treated with Dupixent reached sustained remission of their disease, compared to 6.1% receiving placebo. Additionally, 38.3% of those on Dupixent reported significant relief from itching versus 10.5% in the placebo group, and they required a lower cumulative dose of corticosteroids.
- The approval establishes Dupixent as the first targeted therapy for BP, with additional regulatory applications under review globally, suggesting broader future patient access.
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First Targeted Drug Approved for Blistering Skin Condition
(MedPage Today) -- The FDA approved dupilumab (Dupixent) as the first targeted drug for bullous pemphigoid, a rare blistering skin disease that largely affects elderly patients, drugmakers Sanofi and Regeneron announced. Approval of the injectable...
FDA Approves Regeneron Sanofi Treatment For Rare Autoimmune Skin Disorder - Regeneron Pharmaceuticals (NASDAQ:REGN), Sanofi (NASDAQ:SNY)
The U.S. Food and Drug Administration (FDA) on Friday approved Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Sanofi SA’s (NASDAQ:SNY) Dupixent (dupilumab) for adult patients with bullous pemphigoid (BP), a rare, chronic autoimmune skin disorder. BP primarily affects elderly patients and is characterized by intense itch, painful blisters and lesions, and skin reddening. It can be chronic and relapsing with underlying type 2 inflammation. The b…
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