FDA denies expansion of Dupixent approval for chronic hives treatment

The U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the application to treat chronic spontaneous urticaria (CSU) with the monoclonal antibody Dupixent. The agency stated that the existing clinical data provided by Sanofi and Regeneron was insufficient to support approval for this specific indication.

The regulatory decision did not raise concerns regarding the safety profile or the manufacturing process of the drug. In response, the manufacturers are continuing an ongoing clinical trial, with new data expected by late 2024. This information will be used to address the efficacy requirements cited by the regulator.

CSU, which manifests as persistent, painful hives, remains a significant challenge for patients who do not respond adequately to antihistamines. While Dupixent is currently approved globally for conditions including atopic dermatitis and asthma, this latest development stalls the expansion of its market footprint. Sanofi and Regeneron maintain their commitment to engaging with the FDA to support a potential future approval.