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Sanofi and Regeneron to File sBLA for Dupixent® (dupilumab) to Treat COPD by End of 2023

Nov 27, 2023

Sanofi and Regeneron have announced they plan to file a supplemental biologics licence application (sBLA) with the FDA for Dupixent® (dupilumab) to treat chronic obstructive pulmonary disease (COPD) by the end of 2023.  This application will be based on two phase III clinical trials.

On 20 October 2023, Sanofi and Regeneron received a complete response letter from the FDA regarding its sBLA for Dupixent® for its use in chronic spontaneous urticaria.