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Tarrytown Today
By the People, for the People
Dupixent® Approved in Japan as First Targeted Treatment for Bullous Pemphigoid
Approval based on trial showing over 4 times more Dupixent patients achieved sustained disease remission compared to placebo
Mar. 24, 2026 at 6:03am
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Regeneron Pharmaceuticals and Sanofi announced that the Ministry of Health, Labour and Welfare in Japan has approved Dupixent® (dupilumab) for the treatment of adults with moderate-to-severe bullous pemphigoid (BP). The approval was based on data from a pivotal trial showing more than four times as many patients on Dupixent experienced sustained disease remission compared to placebo at Week 36.
Why it matters
BP is a rare, chronic skin disease characterized by intense itch, painful blisters and lesions. Available treatment options are limited and can suppress the immune system, adding to the overall disease burden. The approval of Dupixent provides a new targeted therapy option for adults with moderate-to-severe BP in Japan.
The details
The pivotal LIBERTY-BP-ADEPT Phase 2/3 trial evaluated Dupixent in 106 adults with moderate-to-severe BP. Patients received Dupixent or placebo every two weeks along with oral corticosteroid treatment. During the trial, patients underwent a protocol-defined oral corticosteroid tapering regimen if disease control was maintained. The primary endpoint evaluated the proportion of patients achieving sustained disease remission at Week 36, defined as complete clinical remission with completion of oral corticosteroid taper by Week 16 without relapse.
- The LIBERTY-BP-ADEPT trial was conducted over a 52-week treatment period.
- Dupixent was approved by the Ministry of Health, Labour and Welfare in Japan on March 24, 2026.
The players
Regeneron Pharmaceuticals, Inc.
A leading biotechnology company that invents, develops and commercializes life-transforming medicines.
Sanofi
An R&D driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth.
Dupixent
A fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant.
Bullous Pemphigoid
A rare, chronic skin disease primarily affecting elderly patients, characterized by intense itch, painful blisters and lesions, and reddening of the skin.
The takeaway
The approval of Dupixent in Japan for bullous pemphigoid represents an important advancement in the treatment of this rare and chronic skin condition, providing patients with a new targeted therapy option beyond the limited and immunosuppressive treatment options that have been available.
