FDA sets new decision date for Sanofi and Regeneron's Dupixent for chronic hives

The U.S. Food and Drug Administration (FDA) has accepted the resubmitted marketing application from Sanofi and Regeneron for their drug Dupixent (dupilumab) as a treatment for chronic spontaneous urticaria (CSU). The FDA has set a target review date of April 18 next year for this application. If the drug is approved, it will be the first targeted treatment for CSU in over a decade.

Dupixent is a dual inhibitor of IL-4 and IL-13 signaling pathways. Its journey toward approval for CSU has faced challenges. Last October, the FDA initially rejected the application, citing the need for additional efficacy data from the Phase III LIBERTY-CUPID program. This program included multiple studies, with Study A showing significant reductions in itch and hives among patients who had not previously been treated with biologics. However, Study B, which was focused on patients who had not responded to Novartis and Roche’s Xolair (omalizumab), was halted due to insufficient efficacy, showing only “positive numerical trends” rather than clear success.

In response to the FDA’s request, Sanofi and Regeneron included data from an additional trial, known as Study C, in their revised application. This study provided further evidence of Dupixent's efficacy in reducing CSU symptoms for patients who did not respond to standard antihistamines.

Dupixent has already been approved for CSU in Japan and is currently under review for the same indication in the European Union. Besides its potential use for CSU, Dupixent is approved in the U.S. for various other conditions, including atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis, prurigo nodularis, eosinophilic esophagitis, and most recently, eosinophilic phenotype chronic obstructive pulmonary disease.

Sanofi and Regeneron's Dupixent generated €10.7 billion ($11.3 billion) in sales last year. Analysts predict that its annual revenue could exceed €20 billion ($21.1 billion) by 2030, although this projection is tempered by the eventual expiration of its patent and the potential emergence of biosimilar competition.

In conclusion, the acceptance of the resubmitted application by the FDA marks a significant step for Sanofi and Regeneron's effort to make Dupixent an available treatment for CSU. If approved, it will be the first new targeted therapy for this condition in over a decade, providing a much-needed option for patients who have not found relief with existing treatments. The additional data from Study C strengthens the case for Dupixent’s efficacy and safety, positioning it as a promising option in the therapeutic landscape for CSU.