AT A GLANCE

The FDA has approved Dupixent (dupilumab) as the first targeted treatment for adults with bullous pemphigoid (BP)—a rare, debilitating autoimmune blistering disease that predominantly affects elderly patients. Characterized by relentless itch, widespread blisters, and fragile, infection-prone skin, BP can severely impair quality of life. Current treatments rely heavily on immunosuppressive therapies, which come with significant risks, particularly in older adults.

Dupixent, which inhibits key pathways of type 2 inflammation, demonstrated significant clinical benefits in the ADEPT phase 2/3 trial. Study patients were randomized to receive Dupixent 300 mg (n=53) or placebo (n=53) in addition to oral corticosteroids. At week 36, nearly one in five patients achieved sustained disease remission with Dupixent (18.3%) compared to just 6.1% in the placebo group. Additionally, 38.3% of Dupixent-treated patients experienced meaningful itch reduction versus 10.5% in the placebo group. The treatment was also associated with a lower median cumulative dose of oral corticosteroids (2.8 g vs. 4.1 g), an important step toward minimizing steroid-related complications.

The most commonly reported adverse events included joint pain, conjunctivitis, and herpes viral infections, with a safety profile consistent with prior Dupixent indications.

This approval marks a significant milestone for patients with BP, a disease long underserved by therapeutic innovation. With this decision, Dupixent continues to expand its reach across inflammatory diseases—from asthma to eosinophilic esophagitis—further cementing its role as a cornerstone of type 2 inflammatory disease management.

“Until now, these primarily elderly patients have had limited therapeutic options available, with potential side effects that have often added to their burden,” said Patrick Dunn
Executive Director, International Pemphigus and Pemphigoid Foundation in a press release. “The approval of Dupixent for bullous pemphigoid brings a novel treatment approach to patients and their caregivers, and we are grateful for the tireless efforts of the scientific community who helped us reach this critical milestone.”

DRUG AT A GLANCE
Dupixent (dupilumab) is a monoclonal antibody that blocks IL-4 and IL-13 signaling to treat type 2 inflammatory conditions. Already approved for diseases like asthma, atopic dermatitis, and eosinophilic esophagitis, Dupixent has now received FDA approval for bullous pemphigoid—the first targeted treatment for this rare autoimmune skin disorder. Regulatory applications for this new indication are currently under review in the EU, Japan, and China.