PARIS (dpa-AFX) - Regeneron Pharmaceuticals Inc. (REGN) and French drug major Sanofi S.A. (SNYNF,SNY) announced Friday that the U.S. Food and Drug Administration has approved Dupixent (dupilumab) for the treatment of adult patients with bullous pemphigoid or BP.
Dupixent is now the only targeted medicine to treat patients with BP in the U.S.
BP, which primarily affects elderly patients, is a chronic, debilitating and relapsing rare skin disease, characterized by intense itch, painful blisters and lesions, as well as reddening of the skin. It is affecting around 27,000 adults in the country whose disease is uncontrolled by systemic corticosteroids.
Dupixent is an injection administered under the skin (subcutaneous injection) at different injection sites.
The FDA approval was based on data from the pivotal ADEPT Phase 2/3 trial that evaluated the efficacy and safety of Dupixent compared to placebo in adults with moderate-to-severe BP. The results showed improvements in sustained disease remission and reductions in itch and oral corticosteroid use compared to placebo.
In the elderly population, the most common adverse events more frequently observed in patients on Dupixent compared to placebo were arthralgia, conjunctivitis, blurred vision, herpes viral infections and keratitis.
George Yancopoulos, Board co-Chair, President and Chief Scientific Officer at Regeneron, and a principal inventor of Dupixent noted that Dupixent has shown the potential to improve the most challenging effects of bullous pemphigoid, while helping some patients achieve sustained disease remission and decreased oral corticosteroid use.
Alyssa Johnsen, Global Therapeutic Area Head, Immunology and Oncology Development at Sanofi, said, 'Until now, treating bullous pemphigoid was very challenging for elderly patients struggling with the debilitating impact of blisters and lesions, and potentially co-morbid conditions. By addressing two central drivers of the underlying type 2 inflammation that contributes to bullous pemphigoid, Dupixent is the first targeted medicine to allow patients the potential to achieve sustained remissionand reduce itch. This approval in the U.S. is important for the thousands of patients living with bullous pemphigoid, and we look forward to working with regulators around the world to bring this innovative medicine to more patients in need.'
In the U.S., Dupixent is now approved to treat eight distinct diseases with underlying type 2 inflammation, including diseases of the skin, gut, and respiratory system that affect various patients, from infants to elderly people.
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