FDA Approves Dupilumab (Dupixent) for Bullous Pemphigoid in Adult Patients

The US Food and Drug Administration (FDA) has approved dupilumab (Dupixent) for the treatment of adult patients living with bullous pemphigoid.1

The June 20, 2025, approval announcement by Sanofi and Regeneron is based on positive clinical trial findings in the ADEPT trial and marks the first targeted therapy to receive approval from the FDA as well as the 8th indication for dupilumab in a disease with underlying type 2 inflammation.1

“Today’s approval extends the remarkable ability of Dupixent to transform treatment paradigms for people living with a variety of diseases with underlying type 2 inflammation, from common conditions like asthma and atopic dermatitis, to rarer ones such as eosinophilic esophagitis and prurigo nodularis, and now including bullous pemphigoid,” George D. Yancopoulos, MD, PhD, Board co-chair, president and chief scientific officer at Regeneron, and principal inventor of Dupixent, said in a statement.1 “Dupixent has shown the potential to improve the most challenging effects of bullous pemphigoid, while helping some patients achieve sustained disease remission and decreased oral corticosteroid use."

Bullous pemphigoid is a chronic autoimmune skin disease known to mostly impact older patients and is estimated to affect close to 27,000 adults for whom systemic corticosteroids do not provide an adequate treatment response. The type-2 inflammation-driven disease is characterized by severe itch, widespread redness, and blisters, potentially leading to lasting skin damage that can impact patients’ quality of life.

Dupilumab is formulated as a fully human monoclonal antibody, inhibiting the interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling pathways among patients with bullous pemphigoid. The IL-4 and IL-13 pathways are known to be key drivers of type-2 inflammation among such individuals. The drug itself differs slightly from traditional immunosuppressants, as it avoids broadly suppressing patients’ immune systems while still reducing inflammation.

The approval of dupilumab for bullous pemphigoid was based on the positive results of the ADEPT pivotal clinical trial program evaluating the drug’s efficacy and safety among 106 adult patients with moderate-to-severe bullous pemphigoid.1

In their approval announcement, Sanofi and Regeneron noted the FDA included an updated analysis of the trial in their labeling. In the 36-week data from ADEPT analysis, results indicated 18.3% of dupilumab-treated patients experienced sustained disease remission compared to 6.1% (12.2% difference; 95% confidence interval, -0.8% to 26.1%). Additionally, 38.3% of dupilumab-treated patients achieved clinically meaningful itch reduction compared to 10.5% with placebo. Sustained remission was defined by the researchers as complete clinical remission and successful tapering off of oral corticosteroids by the 16-week point in the study.1

The trial also demonstrated dupilumab-treated patients reduced their median cumulative oral corticosteroid dose to 2.8 grams compared to 4.1 grams with placebo.1

The study’s safety findings suggested the most common adverse events were joint pain, back pain, peripheral edema, upper respiratory tract infections, limb injury, hypertension, blurred vision, asthma, conjunctivitis, constipation, and insomnia, with occurrences among at least 3 individuals.1,2,3

Prior to this approval, the companies announced in February their supplemental biologics license application (sBLA) submission had been granted priority review by FDA officials. Dupilumab has been given regulatory approvals in over 60 countries for such diseases as prurigo nodularis, atopic dermatitis, and chronic spontaneous urticaria. Its development is a collaborative effort between Sanofi and Regeneron.1,2,3

“By addressing two central drivers of the underlying type 2 inflammation that contributes to bullous pemphigoid, Dupixent is the first targeted medicine to allow patients the potential to achieve sustained remission and reduce itch," Alyssa Johnsen, MD, PhD, Global Therapeutic Area Head, Immunology and Oncology Development at Sanofi, said in a statement.1 "This approval in the U.S. is important for the thousands of patients living with bullous pemphigoid, and we look forward to working with regulators around the world to bring this innovative medicine to more patients in need.”

References

1. Regeneron Pharmaceuticals Inc. Dupixent® (dupilumab) Approved in the U.S. as the Only Targeted Medicine to Treat Patients with Bullous Pemphigoid (BP) | Regeneron Pharmaceuticals Inc. Regeneron Pharmaceuticals Inc. Published June 20, 2025. Accessed June 20, 2025. https://investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-approved-us-only-targeted-medicine-treat

2. Smith T. FDA Grants Priority Review for Dupilumab in Adults with Bullous Pemphigoid. HCPLive. February 18, 2025. https://www.hcplive.com/view/fda-grants-priority-review-for-dupilumab-adults-with-bullous-pemphigoid. Accessed June 13, 2025.

3. Press Release: Dupixent is the first and only biologic to achieve significant improvements in disease remission and symptoms in bullous pemphigoid positive pivotal study. Sanofi - Aventis Groupe. February 18, 2025. https://www.globenewswire.com/news-release/2025/02/18/3027482/0/en/Press-Release-Dupixent-sBLA-accepted-for-FDA-priority-review-for-the-targeted-treatment-of-bullous-pemphigoid.html. Accessed June 13, 2025.