Sanofi's Dupixent Approved in US for Rare Skin Disease
The U.S. Food and Drug Administration (FDA) has approved Sanofi's Dupixent (dupilumab) for the treatment of adult patients with bullous pemphigoid (BP).
Paris and Tarrytown, NY – June 20, 2025 – The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of adult patients with bullous pemphigoid (BP).
BP is a rare, chronic, and relapsing skin disease characterized by intense itch, painful blisters, and skin lesions. For patients whose disease is not controlled by systemic corticosteroids, a new targeted treatment is now available. Previous treatment options were limited and often increased a patient's disease burden by suppressing the immune system.
The FDA approval is based on pivotal results from the ADEPT study, which demonstrated that Dupixent significantly improved disease remission, reduced itch, and decreased the use of oral corticosteroids compared to placebo. In the study, 38.3% of patients in the Dupixent group experienced a clinically meaningful reduction in itch, compared to 10.5% in the placebo group.
The underlying cause of the disease is type 2 inflammation, which Dupixent targets. Dupixent is now approved in the U.S. for eight distinct diseases associated with type 2 inflammation, including skin, respiratory, and gastrointestinal conditions. Pharmaceutical company Sanofi and its partner Regeneron announced the approval, which opens new treatment avenues for thousands of patients.