Regeneron and Sanofi presented positive late-breaking data from the ADEPT Phase 2/3 trial at the American Academy of Dermatology Annual Meeting, demonstrating the effectiveness of Dupixent (dupilumab) in treating moderate-to-severe bullous pemphigoid (BP). The study showed that five times more patients on Dupixent achieved sustained disease remission at 36 weeks compared to placebo. Dupixent also significantly reduced disease severity, itch, and the need for oral corticosteroids.

The trial enrolled 106 adults, with patients receiving Dupixent every two weeks or a placebo alongside standard oral corticosteroids. Key findings at 36 weeks included 20% of Dupixent-treated patients achieving sustained remission versus 4% on placebo, 40% showing a ≥90% reduction in disease severity, and a significant reduction in corticosteroid use. Safety findings were consistent with previous studies, with the most common side effects including peripheral edema, joint pain, and upper respiratory infections.

Regulatory submissions for Dupixent in BP are under review in the U.S. and Europe, with an FDA decision expected by June 20, 2025. If approved, Dupixent would be the first targeted therapy for BP, a chronic and debilitating autoimmune skin disease driven by type 2 inflammation.

Opella, Sanofi's Consumer Healthcare business, announced that the FDA has lifted a clinical hold on its planned actual use trial (AUT) for Cialis, paving the way to potentially switch the medication from prescription-only to over-the-counter (OTC) availability. The AUT will evaluate Cialis under real-world conditions to confirm its safe and effective self-use by consumers without a healthcare provider's guidance. This marks the first time a PDE-5 inhibitor has reached such a milestone, reflecting Opella's commitment to advancing self-care solutions for erectile dysfunction (ED).

Julie Van Ongevalle, President and CEO of Opella, emphasized the significance of this step in enhancing consumer self-care, while Chief Science Officer Dr. Josephine Fubara noted the trial's importance in ensuring safety and proper use. The trial is part of Opella's broader efforts to develop OTC Cialis, which is currently available only by prescription to treat ED, benign prostatic hyperplasia (BPH), or both conditions. Sanofi remains dedicated to its mission of improving healthcare accessibility while maintaining a focus on sustainability and social responsibility.