FDA Approves Dupilumab for CSU in Adults 12 and Older

The US Food and Drug Administration (FDA) has approved dupilumab (Dupixent, Regeneron Pharmaceuticals, Inc. and Sanofi) for the treatment of adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with histamine-1 (H1) antihistamine treatment, Regeneron and Sanofi announced.

CSU becomes the seventh FDA-approved indication for dupilumab. It is the first new FDA-approved therapy for CSU in more than 10 years, according to Regeneron.

“People with chronic spontaneous urticaria experience sudden, unpredictable hives and severe itch that cause a significant, and often overwhelming, burden on their everyday lives,” Kenneth Mendez, president and chief executive officer at the Asthma and Allergy Foundation of America, said in a press release. “The approval of this treatment offers patients more options and the chance to control their disease.”

A supplemental biologics license application (sBLA) had been accepted by the FDA in November, supported by data from the multi-study LIBERTY-CUPID phase 3 clinical program from dupilumab in CSU. Study C, the second LIBERTY-CUPID pivotal study in biologic-naïve patients, met its primary and key secondary endpoints, confirming results seen in the previous Study A. Results showed dupilumab significantly reduced itch and urticaria activity. Safety results in all LIBERTY-CUPID phase 3 studies were generally consistent with the known safety profile of dupilumab in its approved indications.

“Dupixent is the first new targeted treatment for chronic spontaneous urticaria, or CSU, in more than 10 years, with pivotal trials demonstrating its ability to help patients significantly reduce the hallmark symptoms of intense itch and unpredictable hives associated with this disease,” said George D. Yancopoulos, MD, PhD, Board co-chair, president and chief scientific officer at Regeneron, and a principal inventor of Dupixent. “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.”