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FDA Approves Regeneron and Sanofi’s Dupixent for Bullous Pemphigoid

The FDA cited ADEPT Phase 2/3 trial data showing sustained remission alongside reduced corticosteroid exposure in elderly patients.

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Overview

  • Bullous pemphigoid primarily affects the elderly and manifests as intense itching, painful blisters and lesions that heighten infection risk.
  • The pivotal ADEPT Phase 2/3 trial randomized 53 adults to Dupixent plus steroid therapy and 53 to placebo under a standardized corticosteroid taper protocol.
  • At 36 weeks, 18.3% of Dupixent-treated patients achieved sustained disease remission compared with 6.1% in the placebo group.
  • Dupixent recipients required a median cumulative oral corticosteroid dose of 2.8 grams versus 4.1 grams for placebo treatment.
  • Reported adverse events more common with Dupixent included arthralgia, conjunctivitis, blurred vision, herpes viral infections and keratitis, along with one case of acute generalized exanthematous pustulosis.