The US Food and Drug Administration (FDA) has approved Sanofi and Regeneron’s Dupixent (dupilumab) to treat adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 (H1) antihistamine treatment.

The US approval is based on data from two phase 3 clinical studies, Study A (n=136) and Study C (n=148), which included biologic-naïve patients aged 12 years and older who were symptomatic despite the use of antihistamines and assessed Dupixent as an add-on therapy to standard-of-care antihistamines, compared to antihistamines alone. Both studies met their primary and key secondary endpoints, with Dupixent demonstrating reductions in itch severity and urticaria activity (a composite of itch and hives) compared to placebo at 24 weeks.

Dupixent also increased the likelihood of well-controlled disease or complete response compared to placebo at 24 weeks. Study B (n=108) provided additional safety data and evaluated Dupixent in patients aged 12 years and older who were inadequate responders or intolerant to anti-IgE therapy and symptomatic despite antihistamine use.

Safety results from Study A, Study B, and Study C were consistent with the known safety profile of Dupixent in its approved indications. In pooled data from all three studies, the most common adverse event (≥2%) more frequently observed in patients on Dupixent compared to placebo was injection site reactions.

Dupixent is already approved for CSU in Japan, the United Arab Emirates, and Brazil. Submissions are currently under review with other regulatory authorities around the world, including in the EU.

George D. Yancopoulus, President and Chief Scientific Officer at Regeneron said, “With this FDA decision, Dupixent is now approved for seven chronic, debilitating atopic conditions driven in part by underlying type 2 inflammation, several of which have been shown to co-morbidly occur with CSU, such as atopic dermatitis and asthma – providing patients with one treatment that might help multiple atopy conditions. We look forward to bringing Dupixent to the more than 300,000 CSU patients in the US with inadequately controlled disease on standard-of-care treatment who, until now, had limited treatment options.”