Sanofi has withdrawn its European regulatory application for Dupixent to treat moderate-to-severe bullous pemphigoid due to the European Medicines Agency (EMA) citing insufficient efficacy and unresolved critical issues from the clinical trial. This withdrawal, despite prior FDA approval for the same indication in the US, represents a setback for Sanofi and Regeneron in expanding Dupixent's market in Europe for this specific condition.
Sanofi (SNY) has withdrawn its European regulatory application for Dupixent to treat moderate-to-severe bullous pemphigoid. This decision was prompted by the European Medicines Agency's (EMA) concerns regarding insufficient efficacy and limitations in the clinical trial design, leading to the conclusion that risks outweighed benefits. While Dupixent received FDA approval for this indication in the US in June 2025, the European setback means Sanofi and co-developer Regeneron (REGN) will miss out on a potential market expansion in Europe for this specific autoimmune skin condition. This is a short-term negative for both companies as it limits Dupixent's growth trajectory for this indication, though Dupixent has many other approved uses. Traders should note the EMA's rigorous stance and its potential implications for other drug approvals.