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Dupixent® (dupilumab) Approved in Japan as the First Targeted Medicine to Treat Adults with Bullous Pemphigoid (BP)
Approval in moderate-to-severe patients was based on pivotal trial results showing over four times more Dupixent patients experienced sustained disease
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"Approval in moderate-to-severe patients was based on pivotal trial results showing over four times more Dupixent patients experienced sustained disease remission through Week 36 compared with placebo BP is a chronic, relapsing skin disease with underlying type 2 inflammation characterized by intense itch alongside painful blisters and other lesions BP is the seventh approved indication for Dupixent in Japan TARRYTOWN, N.Y. and PARIS, March 24, 2026 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the Ministry of Health, Labour and Welfare (MHLW) in Japan has approved Dupixent® (dupilumab) for the treatment of adults with moderate-to-severe bullous pemphigoid (BP). The approval in Japan is based on data from the pivotal LIBERTY-BP-ADEPT Phase 2/3 trial, which evaluated Dupixent in adults with moderate-to-severe BP. Patients were randomized to receive Dupixent 300 mg (n=53) or placebo (n=53) added to standard-of-care oral corticosteroids (OCS). During treatment, all patients underwent a protocol-defined OCS tapering regimen if control of disease activity was maintained. For the primary endpoint, more than four times as many patients on Dupixent experienced sustained disease remission compared to placebo (18% vs. 4%; p=0.0250) at Week 36 in the companies’ core dataset used for the regulatory submission in Japan. Treatment-related adverse events (AEs) occurred in 26% of Dupixent patients and 15% of placebo patients. The treatment-related AE most commonly reported with Dupixent was conjunctivitis (4%). In addition to BP, Dupixent is approved in Japan in certain patients with atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis, chronic spontaneous urticaria (CSU) and chronic obstructive pulmonary disease (COPD). About BPBP is a rare skin disease that primarily affects elderly patients, and is characterized by intense itch, painful blisters and lesions, as well as reddening of the skin. It can be chronic and relapsing with underlying type 2 inflammation. The blisters and rash can form over much of the body and cause the skin to bleed and break down, resulting in patients being more prone to infection and affecting their daily functioning. Available treatment options are limited and can add to overall disease burden by suppressing a patient’...