Japan’s MHLW has approved Dupixent (dupilumab) for adults with moderate-to-severe bullous pemphigoid based on results from the LIBERTY-BP-ADEPT Phase 2/3 trial showing significantly higher sustained disease remission versus placebo.
Written By: Chikkula Pavan Kumar, PharmD
Reviewed By: Pharmacally Editorial Team
Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Dupixent® (dupilumab) for the treatment of adults with moderate-to-severe bullous pemphigoid (BP), marking a new therapeutic option for patients with the rare autoimmune blistering skin disorder. The therapy is jointly developed by Regeneron Pharmaceuticals and Sanofi.
The approval is supported by results from the pivotal LIBERTY-BP-ADEPT Phase 2/3 clinical trial (NCT04206553), which evaluated the efficacy and safety of Dupixent in adults with moderate-to-severe BP. In the study, 106 patients were randomized to receive Dupixent 300 mg (n=53) or placebo (n=53) on top of standard-of-care oral corticosteroids (OCS). Patients followed a protocol-defined corticosteroid tapering schedule once disease control was achieved.
At Week 36, more than four times as many patients receiving Dupixent achieved sustained disease remission compared with placebo (18% vs. 4%; p=0.0250) in the dataset submitted for regulatory review in Japan. Sustained remission was defined as complete clinical remission with successful completion of corticosteroid tapering by Week 16, without relapse or need for rescue therapy during the 36-week treatment period.
The ADEPT study was a randomized, double-blind, placebo-controlled trial conducted over 52 weeks. Patients received Dupixent or placebo every two weeks after an initial loading dose, alongside oral corticosteroids. Corticosteroid tapering began after two weeks of sustained disease control and was intended to be completed by Week 16. After tapering, patients continued treatment with Dupixent or placebo alone, with rescue therapy permitted if necessary.
Regarding safety, treatment-related adverse events occurred in 26% of patients treated with Dupixent compared with 15% in the placebo group. The most commonly reported treatment-related adverse event associated with Dupixent was conjunctivitis (4%).
Bullous pemphigoid is a rare, chronic inflammatory skin disease that mainly affects elderly individuals. The condition is characterized by intense itching, painful blisters, and widespread skin lesions. The disease can be relapsing and is driven in part by type 2 inflammation, with lesions that may rupture and leave patients vulnerable to infections. Current treatment options are limited and often involve systemic immunosuppressive therapies that can increase overall treatment burden.
Dupixent is a fully human monoclonal antibody that inhibits signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, key drivers of type 2 inflammation. The therapy is not classified as an immunosuppressant. In Japan, Dupixent will be available as a 300 mg pre-filled syringe or pre-filled pen, administered by subcutaneous injection every two weeks after an initial loading dose. Patients may receive the treatment in a clinical setting or self-administer it at home following appropriate training.
The therapy has already been approved in Japan for multiple type 2 inflammatory conditions, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis, chronic spontaneous urticaria (CSU), and chronic obstructive pulmonary disease (COPD).
Globally, Dupixent has been approved in more than 60 countries across several indications, including atopic dermatitis, allergic fungal rhinosinusitis, asthma, CRSwNP, eosinophilic esophagitis, prurigo nodularis, CSU, COPD, and bullous pemphigoid in various age groups. More than 1.4 million patients worldwide have been treated with the therapy.
Dupilumab continues to be studied in a broad development program across diseases driven by type 2 inflammation. Ongoing Phase 3 trials are evaluating the therapy in conditions such as chronic pruritus of unknown origin and lichen simplex chronicus, though these indications remain investigational.
Reference
Dupixent® (dupilumab) Approved in Japan as the First Targeted Medicine to Treat Adults with Bullous Pemphigoid (BP), 24 March 2026, Dupixent® (dupilumab) Approved in Japan as the First Targeted Medicine to Treat Adults with Bullous Pemphigoid (BP) | Regeneron Pharmaceuticals Inc.
Press Release: Sanofi and Regeneron’s Dupixent approved in Japan as the first targeted medicine to treat adults with bullous pemphigoid, 24 March 2026, Press Release: Sanofi and Regeneron’s Dupixent approved in Japan as the first targeted medicine to treat adults with bullous pemphigoid
A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients with Bullous Pemphigoid (LIBERTY-BP), ClinicalTrials.gov ID NCT04206553, https://clinicaltrials.gov/study/NCT04206553
About the Writer
Chikkula Pavan Kumar, PharmD is a Doctor of Pharmacy with a keen interest in clinical pharmacy, pharmacovigilance, and evidence-based practice. In his words, he is passionate about patient safety and translating complex medical information into clear, research-driven communication.