The FDA has approved Sanofi and Regeneron’s Dupixent as a treatment for adults with bullous pemphigoid, a rare chronic autoimmune skin condition that causes severe itching, painful blisters and open sores.
Bullous pemphigoid primarily affects older adults. Current treatments often rely on systemic corticosteroids, which can come with serious side effects, according to a June 20 news release from Sanofi. Dupixent (dupilumab) works to target Type 2 inflammation, a key cause of the condition.
The FDA approval is based on results from a phase 2 and 3 trial showing that Dupixent led to higher rates of sustained disease remission and reduced itch and corticosteroid use compared to the placebo. At 36 weeks, 18.3% of patients receiving Dupixent had sustained remission, compared to 6.1% using the placebo, the release said.