Sanofi & Regeneron's Dupixent Gets FDA Nod for Bullous Pemphigoid

The FDA has approved Sanofi (SNY) and Regeneron's (REGN) Dupixent for bullous pemphigoid (BP) in adults, making it the first targeted therapy for the rare skin disease in the U.S. The approval was based on Phase II/III data showing significant improvements in disease remission and reduced steroid use compared to placebo. Dupixent, a key revenue driver with Q1 2025 global sales of €3.48 billion (up 20.3%), is now approved for eight type II inflammatory diseases in the U.S., with applications for BP under review in the EU, Japan, and China; Sanofi projects Dupixent sales of €22 billion in 2030.

Analysis

Sanofi (SNY) and Regeneron (REGN) have secured FDA approval for Dupixent for adult patients with bullous pemphigoid (BP), marking it as the first and only targeted therapy for this rare skin disease in the United States. This approval, the eighth for Dupixent in the U.S. for type II inflammatory diseases, is supported by phase II/III ADEPT study data demonstrating significant improvements in sustained disease remission and a reduction in oral corticosteroid use. Bullous pemphigoid affects approximately 27,000 adults in the U.S. whose condition does not improve with steroid treatment. Dupixent is a critical revenue generator for both companies; Sanofi reported global net product sales of €3.48 billion in the first quarter of 2025, a 20.3% increase at constant exchange rates, and projects Dupixent sales to reach approximately €22 billion in 2030. Regeneron recorded $1.18 billion in collaboration revenues from Sanofi in Q1 2025, up 30% year-over-year. Regulatory applications for Dupixent in BP are also under review in the European Union, Japan, and China, indicating further global market potential. Year-to-date, Sanofi's shares have declined 1.2%, slightly outperforming the industry's 1.7% decrease. Sanofi currently holds a Zacks Rank #3 (Hold).

Key Decisions for Investors

• Investors should view the consistent label expansion of Dupixent, now including bullous pemphigoid as its eighth U.S. indication, as a key positive catalyst for sustained revenue growth for both Sanofi and Regeneron.
• The achievement of Dupixent as the first targeted therapy for bullous pemphigoid strengthens its market positioning and supports Sanofi's projection of €22 billion in sales by 2030, warranting close attention to its sales trajectory and market penetration.
• Upcoming regulatory decisions for Dupixent in bullous pemphigoid in the European Union, Japan, and China represent potential value inflection points that should be monitored.
• While Dupixent's outlook is strong, investors in Sanofi should consider the company's current Zacks Rank #3 (Hold) and its year-to-date stock performance of -1.2% within the context of their investment strategy.