PARIS, FRANCE & TARRYTOWN, NEW YORK, USA | March 24, 2026
Sanofi and Regeneron have announced that Japan’s Ministry of Health, Labour and Welfare has granted marketing approval for Dupixent (dupilumab) as the first targeted therapy for adults with moderate-to-severe bullous pemphigoid (BP), a rare and debilitating autoimmune skin disorder. This milestone marks a significant expansion of Dupixent’s global footprint and introduces a novel, non-immunosuppressive treatment option for patients suffering from chronic skin inflammation characterized by intense itching, painful blisters, and high relapse rates.
Strong Clinical Evidence Demonstrates Superior Outcomes
The approval is supported by results from the pivotal LIBERTY-BP-ADEPT Phase 2/3 clinical trial, which demonstrated compelling efficacy in patients receiving Dupixent. Notably, over four times more patients achieved sustained disease remission compared to placebo (18% vs. 4%, p=0.025) at Week 36, highlighting the drug’s significant clinical benefit.
The study also confirmed a manageable safety profile, with treatment-related adverse events reported in 26% of patients, most commonly mild conditions such as conjunctivitis. Importantly, Dupixent enabled patients to reduce or eliminate reliance on oral corticosteroids, which are often associated with serious long-term side effects. These results underscore the therapy’s potential to transform disease management and improve patient quality of life.
Addressing High Unmet Need in Bullous Pemphigoid
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Bullous pemphigoid is a chronic, relapsing autoimmune disease primarily affecting elderly individuals, with symptoms that significantly impair daily functioning and increase infection risk. Existing treatments are limited and often rely on broad immunosuppression, which can further compromise patient health. Dupixent offers a targeted mechanism of action, inhibiting interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling pathways, which are key drivers of type 2 inflammation.
Unlike traditional therapies, Dupixent is not an immunosuppressant, making it a safer and more precise treatment alternative. This approval addresses a critical unmet need and aligns with the growing trend toward targeted biologic therapies in dermatology and immunology.
Expanding Global Leadership in Immunology Therapeutics
With this latest approval, Dupixent now holds seven approved indications in Japan and is authorized in more than 60 countries worldwide, with over 1.4 million patients treated globally. The drug continues to demonstrate versatility across multiple conditions including atopic dermatitis, asthma, chronic rhinosinusitis, COPD, and other inflammatory diseases.
Backed by a robust clinical development program involving over 12,000 patients across 60 studies, Dupixent has established itself as a leading biologic therapy in immune-mediated diseases. Ongoing research aims to expand its use into additional indications driven by type 2 inflammation, reinforcing its position as a blockbuster therapy with broad therapeutic potential.
The approval of Dupixent for bullous pemphigoid in Japan represents a major advancement in targeted immunotherapy, offering a safer, more effective treatment option while strengthening Sanofi and Regeneron’s leadership in global biopharmaceutical innovation.
Source: Sanofi, Regeneron press release
