French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) announced on Friday that the US Food and Drug Administration has approved Dupixent (dupilumab) as the first targeted treatment for adult patients with bullous pemphigoid, a rare and debilitating chronic skin condition.

This decision follows data from the ADEPT phase 2/3 study, in which Dupixent demonstrated superior results to placebo in sustained disease remission, itch reduction, and reduced oral corticosteroid use in adults with moderate-to-severe bullous pemphigoid.

The study showed that 18.3% of patients receiving Dupixent achieved sustained remission at 36 weeks, compared to 6.1% in the placebo group. Additionally, 38.3% of Dupixent-treated patients reported meaningful itch relief versus 10.5% on placebo, while also requiring a lower median cumulative dose of corticosteroids (2.8g vs. 4.1g).

Bullous pemphigoid affects approximately 27,000 adults in the United States, predominantly elderly patients, and is characterised by painful blisters, intense itch, and increased risk of infection due to skin breakdown.

Existing treatments are limited and often involve immunosuppressive therapies that carry additional risks. Dupixent now becomes the only FDA-approved targeted medicine for this population.

The drug was evaluated under priority review and holds orphan drug designation for bullous pemphigoid, underscoring its role in addressing a significant unmet medical need.

Dupixent is now approved in the United States to treat eight diseases driven by type 2 inflammation across dermatology, gastroenterology, and respiratory medicine.

Dupilumab is being jointly developed by Sanofi and US biotechnology company Regeneron Pharmaceuticals Inc (Nasdaq:REGN) under a global collaboration agreement.