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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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stocktitan.net broke the news in on Friday, June 20, 2025.
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