Regeneron and Sanofi Secure FDA Approval for Dupixent in Adult Bullous Pemphigoid Treatment

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The U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for the treatment of bullous pemphigoid (BP) in adults, a chronic skin disease that primarily affects the elderly. This approval is based on results from the ADEPT trial, which demonstrated that Dupixent leads to sustained disease remission in 18.3% of patients compared to 6.1% for the placebo, alongside significant reductions in itch and the median cumulative dose of oral corticosteroids (2.8g vs. 4.1g).

Approximately 27,000 adults in the U.S. suffer from BP, which causes severe itching and painful blisters. Dupixent is now approved for eight diseases associated with type 2 inflammation. The most common side effects, reported in over 2% of patients, include joint pain, conjunctivitis, and blurred vision. Dupixent was evaluated under Priority Review due to its potential to improve treatment outcomes for serious conditions with limited options.

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