The U.S. Food and Drug Administration has approved Dupixent (dupilumab) as the first targeted treatment for adults with bullous pemphigoid (BP), a rare, chronic autoimmune skin disease that primarily affects the elderly. Affecting around 27,000 adults in the U.S., BP is marked by intense itching, painful blisters, and increased risk of infection due to skin damage. Current treatments rely heavily on systemic corticosteroids, which can have serious side effects.
Approval was based on pivotal results from the Phase 2/3 ADEPT study, which showed that Dupixent led to sustained disease remission in 18.3% of patients, reduced itch in 38.3%, and lowered cumulative corticosteroid use compared to placebo. The treatment, already approved for seven other inflammatory conditions, now adds BP to its list of indications.
Dupixent was granted priority review and orphan drug designation by the FDA for BP, underscoring its potential to significantly improve outcomes in a patient population with limited treatment options. Regulatory reviews are also underway in the EU, Japan, and China.
Janette Wider | Editor-in-Chief
Janette Wider is Editor-in-Chief for Healthcare Purchasing News.
