> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Complete Response on Dupixent sBLA
- URL: https://www.fdaweb.com/complete-response-on-dupixent-sbla/
- Published: 2023-10-23T12:00:00.000Z
- Updated: 2026-09-14T14:14:01.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5155624

FDA has issued Sanofi and Regeneron a complete response letter on their supplemental BLA for Dupixent (dupilumab) and its use in chronic spontaneous urticaria, described by the companies as an inflammatory skin condition, which causes sudden, debilitating hives and swelling on the skin.

The letter indicates that “additional efficacy data are required to support an approval; it did not identify any issues with safety or manufacturing,” according to the companies. “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.”

Monoclonal antibody Dupixent works by inhibiting the signaling of the IL-4 and IL-13 pathways, the companies say. It’s currently approved for treating atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, prurigo nodularis and eosinophilic esophagitis.