- In September 2021, the Phase 3 PEGASUS trial evaluated rilzabrutinib in adults with moderate-to-severe pemphigus vulgaris or foliaceus, a rare autoimmune skin disorder. Although rilzabrutinib showed a consistent safety profile with no new concerns, the study did not meet its primary or key secondary endpoints. The primary goal—complete remission between weeks 29 and 37 with low-dose corticosteroids—was not significantly different from placebo. This was the first placebo-controlled trial of a BTK inhibitor in pemphigus, highlighting the challenge of treating this complex condition
- In February 2025, Regeneron and Sanofi submitted a supplemental Biologics License Application (sBLA) to the U.S. FDA for Dupixent to treat adults with Bullous Pemphigoid (BP), a rare autoimmune blistering disorder. This submission is based on positive data from the ADEPT Phase 2/3 trial, which showed that Dupixent significantly improved disease remission, reduced disease severity, and alleviated itch in BP patients. The FDA accepted the application for Priority Review, with a decision expected by June 20, 2025. This collaboration aims to provide a new treatment option for patients with BP, further expanding Dupixent’s role in autoimmune blistering diseases
- In March 2025, Regeneron expanded its research into Dupixent’s potential for treating Pemphigus Vulgaris (PV), following its success in Bullous Pemphigoid (BP). Both BP and PV share underlying type 2 inflammation mechanisms, positioning Dupixent as a promising candidate for PV treatment. Ongoing studies are evaluating Dupixent’s efficacy in PV, with early results suggesting potential benefits. This exploration aims to provide a new treatment option for patients with PV, further expanding Dupixent’s application in autoimmune blistering diseases
- In April 2025, the Merck & Co., Inc. announced the groundbreaking of a cutting-edge biologics center of excellence in Wilmington, Delaware, spanning 470,000 square feet and representing a USD 1 billion investment
- In September 2024, Sanofi biologics Dupixent demonstrated significant improvements in disease remission and symptoms in both bullous pemphigoid (BP) and pemphigus vulgaris (PV), rare and life-threatening autoimmune skin diseases. In the ADEPT Phase 3 trial, five times more patients with BP on Dupixent achieved sustained remission compared to those on placebo. The study met its primary and all key secondary endpoints, showing a strong steroid-sparing effect. Dupixent is poised to become the first targeted treatment for BP and PV in the U.S. and EU, pending regulatory approval
