Sanofi and Regeneron set to file for FDA approval of Dupixent for COPD

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Sanofi and Regeneron set to file for FDA approval of Dupixent for COPD
Credit: © Reuters.

Sanofi (EPA: SASY ) (NASDAQ: SNY ) and Regeneron (NASDAQ: REGN ) Pharmaceuticals are preparing for an accelerated filing with the U.S. Food and Drug Administration (FDA) for their drug Dupixent (dupilumab) before the end of December, following promising trial results. Dupixent, already known for treating conditions such as asthma and atopic dermatitis, has now shown efficacy in a second Phase 3 trial, NOTUS, for treating chronic obstructive pulmonary disease (COPD).

The NOTUS trial met its primary endpoint, demonstrating a significant 34% reduction in COPD exacerbations. This success mirrors the results from the earlier Phase III BOREAS trial. The European Medicines Agency (EMA) is currently reviewing similar data. If approved, Dupixent would become the first biologic treatment available for patients with COPD, representing a substantial new market opportunity.

George Yancopoulos, the Chief Scientific Officer of Regeneron, expressed readiness for an urgent FDA submission, highlighting the potential impact of Dupixent in treating COPD. The New England Journal of Medicine has documented the significance of this development, indicating the potential for Dupixent to enter a massive new therapeutic area.

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