Regeneron and Sanofi announced that the FDA accepted for Priority Review their supplemental Biologics License Application for Dupixent (dupilumab) to treat bullous pemphigoid (BP) in adults. The application is supported by positive pivotal trial data showing significantly improved sustained disease remission rates with Dupixent compared to placebo. Specifically, five times more Dupixent patients achieved sustained remission—defined as complete remission off oral corticosteroids for at least 20 weeks without relapse or rescue therapy during the 36-week treatment period.
This development is potentially transformative for BP patients, who currently rely heavily on systemic corticosteroids with their associated side effects. If approved, Dupixent offers the possibility of sustained remission and reduced reliance on these corticosteroids, improving quality of life for this patient population. This advancement also demonstrates the potential of targeting type 2 inflammation in addressing a range of dermatological diseases, opening avenues for future research and development.
The pivotal trial enrolled 106 adults with moderate-to-severe BP. Beyond the primary endpoint of sustained remission, Dupixent also demonstrated significant improvements in disease severity and itch reduction. Observed adverse events with Dupixent (in at least 3 patients) compared to placebo included peripheral edema, arthralgia, back pain, blurred vision, hypertension, asthma, conjunctivitis, constipation, upper respiratory tract infection, limb injury, and insomnia. The FDA is expected to make a decision by June 20, 2025, and if approved, Dupixent would be the first targeted therapy for BP in the U.S.
A potential approval for Dupixent in BP could significantly expand the drug’s market reach and solidify its position as a key player in treating type 2 inflammatory diseases. This positive news also strengthens the collaboration between Regeneron and Sanofi and validates their focus on developing innovative treatments for unmet medical needs. It may also stimulate further research into the role of type 2 inflammation in other related skin diseases.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
