French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) and US biotechnology company Regeneron Pharmaceuticals Inc (Nasdaq:REGN) said on Tuesday that they have received marketing and manufacturing authorisation in Japan for Dupixent (dupilumab) to treat adults with moderate-to-severe bullous pemphigoid, marking the first targeted medicine approved in the country for this condition.

The decision was granted by Japan's Ministry of Health, Labour and Welfare and represents the seventh approved indication for Dupixent in Japan.

Bullous pemphigoid is a chronic, relapsing skin disease driven by type 2 inflammation and characterised by intense itching, painful blisters, and lesions that can affect large areas of the body.

The approval is supported by results from the LIBERTY-BP-ADEPT Phase 2/3 study, in which patients receiving Dupixent plus standard-of-care oral corticosteroids achieved sustained disease remission at a higher rate than placebo (18% versus 4%) at Week 36, with more than four times as many responders in the treatment group. The study included a structured corticosteroid tapering regimen based on disease control.

Reported treatment-related adverse events occurred in 26% of Dupixent patients versus 15% in the placebo group, with conjunctivitis being the most common treatment-related event.

Dupixent is also approved in Japan for multiple indications including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, prurigo nodularis, chronic spontaneous urticaria, and chronic obstructive pulmonary disease.