Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi today announced that 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) whose disease is not adequately controlled by existing therapies.
This milestone marks the seventh indication for Dupixent in Japan and establishes it as the first targeted therapy available for BP patients in the country, addressing a significant unmet need for a condition characterized by widespread, painful skin blistering.
The MHLW’s decision was primarily based on results from the LIBERTY-BP-ADEPT Phase 2/3 trial.
In this study, patients receiving Dupixent in combination with a corticosteroid taper achieved a sustained remission rate of 18% at Week 36, compared to just 4% in the placebo group (p=0.0250).
The trial demonstrated that Dupixent could significantly improve clinical outcomes while allowing for a reduction in the use of oral corticosteroids, which are associated with severe long-term side effects in the elderly population typically affected by BP.
The safety profile in the BP trial was generally consistent with the known profile of Dupixent in its other approved dermatological and respiratory indications.
Treatment-related adverse events occurred in 26% of patients in the Dupixent arm versus 15% in the placebo arm.
Notably, conjunctivitis—a known side effect of dupilumab—was reported in 4% of patients receiving the active drug.
Despite these events, the overall benefit-risk assessment remained strongly positive, particularly given the lack of alternative targeted options for this patient population.