- 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 disease
- In April 2025, the Merck & Co., Inc. announced that 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
Frequently Asked Questions
Rising adoption of biologic therapies, increasing use of personalized medicine, growing emphasis on early diagnosis, expansion of patient awareness programs, and advancements in autoimmune disease research are shaping the pemphigus vulgaris market. Collaborations between pharma companies and tech integration also drive innovation.
Emerging treatment options for pemphigus vulgaris and rising adoption of digital health technologies for pemphigus vulgaris treatment management.
Rising concerns over adverse effects of pemphigus vulgaris medications and lack of reimbursement and coverage policies.
