The FDA is requesting additional efficacy data to support an approval for patients with chronic spontaneous urticaria; results of an ongoing study are expected late next year.
The FDA has issued a complete response letter (CRL) for the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat patients with chronic spontaneous urticaria (CSU). The FDA is asking for additional efficacy data to support an approval; it did not identify any issues with safety or manufacturing.
An ongoing clinical trial (Study C) continues to enroll patients, with results expected in late 2024 that are anticipated to provide the additional efficacy data.
Chronic spontaneous urticaria is an inflammatory skin condition that causes sudden hives and swelling on the skin, including the face, hands and feet. CSU, which is estimated to affect between 1% to 2% of the population, is typically treated with H1 antihistamines, which target histamine-1 receptors on cells to control symptoms of urticaria. The disease, however, remains uncontrolled in up to 50% of patients, who are left with limited alternative treatment options.
Developed by Regeneron and Sanofi, Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways. It is approved for multiple indications including atopic dermatitis and asthma. Last year, it was approved for several new uses, including for prurigo nodularis, a rare skin disorder. and for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis. Dupixent also is under review to treat children 1 to 11 years of age with eosinophilic esophagitis (EoE); it was approved in May 2022 for patients 12 years and older. The target action date for the FDA decision is Jan. 31, 2024.
For the chronic spontaneous urticaria indication, Dupixent was studied in three clinical trials in two different patient populations with uncontrolled chronic spontaneous urticaria. Study A evaluated Dupixent as an add-on therapy to standard-of-care H1 antihistamines in patients aged 6 years and older. Efficacy and safety data from Study A were the basis of the sBLA. Study B evaluated Dupixent in 108 patients with CSU aged 12 to 80 years provided additional supporting data for the sBLA. Study C is an ongoing trial investigating Dupixent in the same population as Study A.