Regeneron Pharmaceuticals (NASDAQ: REGN) and Sanofi announced that Japan's Ministry of Health, Labour and Welfare approved Dupixent (dupilumab) for treating adults with moderate-to-severe bullous pemphigoid (BP), marking the first targeted medicine approved for this condition in Japan.

The approval was based on results from the LIBERTY-BP-ADEPT Phase 2/3 trial, which evaluated 106 adults with moderate-to-severe BP. Patients received either Dupixent 300 mg or placebo alongside standard oral corticosteroids. The study showed that 18% of Dupixent patients achieved sustained disease remission at week 36, compared to 4% of placebo patients.

Treatment-related adverse events occurred in 26% of Dupixent patients versus 15% of placebo patients. The most common treatment-related side effect with Dupixent was conjunctivitis, affecting 4% of patients.

Bullous pemphigoid is a chronic skin disease that primarily affects elderly patients, characterized by intense itching, painful blisters and lesions. The condition involves underlying type 2 inflammation and can be relapsing, with limited available treatment options.

This approval represents the seventh indication for Dupixent in Japan, where it is already approved for atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, prurigo nodularis, chronic spontaneous urticaria, and chronic obstructive pulmonary disease in certain patient populations.

Dupixent is a fully human monoclonal antibody that inhibits interleukin-4 and interleukin-13 pathways. The drug has received regulatory approvals in more than 60 countries for various indications and is currently treating over 1.4 million patients globally, according to the companies.