Sanofi SA (NASDAQ:SNY) announced the withdrawal of its regulatory application in Europe for Dupixent (dupilumab) to treat adults with moderate-to-severe bullous pemphigoid.
In June 2025, the U.S. Food and Drug Administration approved Dupixent, developed by Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Sanofi, for adult patients with bullous pemphigoid.
Regulatory Hurdle Leads To Withdrawal
The decision to pull the submission was finalized on June 24, 2026.
Bullous pemphigoid is an autoimmune skin condition characterized by extensive blistering and itching of the skin, and occasionally of the mouth.
The French pharmaceutical giant initially filed to expand Dupixent’s indication for this disease, but later narrowed the scope to target only moderate-to-severe cases during the review process.
Clinical Trial Shortfalls Identified
The submission was based on a primary clinical trial encompassing 106 adult patients. Participants were administered either Dupixent or a placebo alongside standard oral corticosteroid treatments until their condition stabilized.
The trial’s primary goal was achieving sustained remission. This was defined as eliminating the need for corticosteroids by the 16th week of treatment, along with a complete absence of disease relapse and the need for rescue therapy by week 36.
European Agency Cites Insufficient Efficacy
The withdrawal followed a thorough evaluation by the European Medicines Agency.
After presenting inquiries and reviewing Sanofi’s subsequent responses, the regulatory body concluded that several critical issues remained unresolved.
The core clinical trial failed to meet its primary endpoint. Furthermore, secondary outcomes lacked robustness due to limitations inherent in the study’s design.
The agency noted that any observed clinical improvements were minimal and accompanied by significant uncertainty.
Additional supporting data, primarily from real-world use, were insufficient to validate the drug’s efficacy for this specific ailment.
Ultimately, the agency determined that the potential risks of utilizing Dupixent for bullous pemphigoid outweighed its therapeutic benefits.
SNY Stock Price Activity: Sanofi shares were up 1.58% at $45.11 at the time of publication Tuesday, according to Benzinga Pro data.
Photo by HJBC via Shutterstock
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