Sanofi and Regeneron's blockbuster Dupixent rejected by FDA for chronic hives condition
US regulators want to see more efficacy data before they consider approving Sanofi and Regeneron’s Dupixent in a skin condition characterized by chronic hives, Sanofi announced Friday.
The anti-inflammatory megablockbuster was handed a rejection in chronic spontaneous urticaria (CSU), a condition with a patient population that executives have said is “close to the size” of Dupixent’s market in COPD. The complete response letter did not cite any safety or manufacturing issues, according to Sanofi, but it did make clear that “additional efficacy data are required to support an approval.”
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