Regeneron, Sanofi announce FDA acceptance for priority review of Dupixent sBLA
The Fly

Regeneron, Sanofi announce FDA acceptance for priority review of Dupixent sBLA

Regeneron (REGN) and Sanofi (SNY) announced that the FDA has accepted for priority review the supplemental biologics license application, or sBLA, for Dupixent in a sixth potential indication as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease, or COPD. The target action date for the FDA decision is June 27. Regulatory submissions are under review in China and Europe.

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