By VETTAPHARMA reporter – Derek Roche: Sanofi and Regeneron announced that Dupixent (dupilumab) has received marketing and manufacturing authorization in Japan for the treatment of adults with moderate-to-severe bullous pemphigoid (BP), marking the first targeted medicine approved for this condition in the country.
The approval is based on results from the LIBERTY-BP-ADEPT phase 2/3 clinical study (NCT04206553), where patients were randomized to receive Dupixent 300 mg (n=53) or placebo (n=53) alongside standard-of-care oral corticosteroids.
At Week 36, more than four times as many patients treated with Dupixent achieved sustained disease remission compared with placebo (18% vs. 4%; p=0.0250), demonstrating clinically meaningful efficacy in this chronic condition.
Bullous pemphigoid is described as a chronic, relapsing skin disease driven by type 2 inflammation, characterized by intense itching, painful blisters, and skin lesions, often requiring long-term management.
Safety findings showed that treatment-related adverse events occurred in 26% of Dupixent patients compared to 15% with placebo, with conjunctivitis reported in 4% of Dupixent-treated patients as the most common adverse event.
With this approval, Dupixent becomes the seventh approved indication in Japan, adding to its use across multiple type 2 inflammatory diseases including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, prurigo nodularis, chronic spontaneous urticaria, and chronic obstructive pulmonary disease.
