Sanofi and Regeneron win EU approval for Dupixent in chronic spontaneous urticaria

Sanofi SA and Regeneron have received approval from the European Commission for Dupixent (dupilumab) as the first targeted medicine in over a decade for the treatment of moderate-to-severe chronic spontaneous urticaria (CSU) in adults and adolescents aged 12 years and older who have an inadequate response to histamine-1 antihistamines and are naïve to anti-IgE therapy. The approval is based on positive results from two phase 3 clinical studies, demonstrating that Dupixent significantly reduced itch and hives compared to placebo. Dupixent is now approved for CSU patients across the EU and is also authorized for this indication in several other countries, including the US and Japan. This regulatory approval was obtained jointly by Sanofi SA and Regeneron. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Sanofi SA published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001193125-25-306193), on December 03, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT) Original Document: here