The Ministry of Health, Labour and Welfare has granted marketing and manufacturing authorization to Dupixent (dupilumab) for the treatment of adults with moderate-to-severe bullous pemphigoid (BP), a rare and debilitating skin disorder.
The approval is based on results from the pivotal LIBERTY-BP-ADEPT Phase 2/3 clinical trial, which evaluated the efficacy and safety of Dupixent in 106 adult patients with moderate-to-severe BP. In the study, patients received either Dupixent 300 mg or placebo alongside standard-of-care oral corticosteroids (OCS), followed by a structured tapering regimen.
At Week 36, significantly more patients treated with Dupixent achieved sustained disease remission compared to placebo (18 Percent vs. 4 Percent; p=0.0250), meeting the study’s primary endpoint. Sustained remission was defined as complete clinical remission without relapse following corticosteroid tapering and without the need for rescue therapy.
In terms of safety, treatment-related adverse events were reported in 26 Percent of patients receiving Dupixent, compared to 15 Percent in the placebo group. The most commonly reported adverse event was conjunctivitis, observed in 4 Percent of Dupixent-treated patients.
Bullous pemphigoid primarily affects elderly individuals and is characterized by intense itching, painful blisters, and widespread skin lesions. The condition is chronic and relapsing, often associated with type 2 inflammation, and can significantly impact quality of life. Existing treatment options are limited and frequently involve immunosuppressive therapies, which can add to the disease burden.
Dupixent, a fully human monoclonal antibody, works by inhibiting interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling pathways—key drivers of type 2 inflammation. Notably, it is not classified as an immunosuppressant, offering a differentiated mechanism of action compared to conventional therapies.
The therapy is now available in Japan as a 300 mg pre-filled syringe or pen for subcutaneous administration every two weeks, following an initial loading dose. Patients may receive the treatment in clinical settings or self-administer at home after appropriate training.
Developed jointly by Sanofi and Regeneron Pharmaceuticals, Dupixent has already been approved in more than 60 countries for multiple indications, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, prurigo nodularis, chronic spontaneous urticaria, and chronic obstructive pulmonary disease.
Globally, more than 1.4 million patients have been treated with Dupixent, supported by a robust clinical development program involving over 12,000 patients across more than 60 studies. Ongoing research continues to explore its potential in additional type 2 inflammatory and allergic conditions.
This latest approval further strengthens Dupixent’s expanding global footprint and underscores its role as a key therapy in managing diseases driven by type 2 inflammation.
