FDA Delays Decision on Sanofi (SNY)-Regeneron Dupixent in COPD

Published on 31 May 2024 on Zacks via Yahoo Finance

FDA Delays Decision on Sanofi (SNY)-Regeneron Dupixent in COPD

Sanofi SNY and Regeneron REGN announced that the FDA extended the review period for a regulatory filing seeking label expansion for their blockbuster drug Dupixent in chronic obstructive pulmonary disease (COPD) indication by an additional three months. A final decision is now expected by Sep 27, 2024.

The FDA filing seeks approval for Dupixent as an add-on maintenance treatment in certain adult patients with uncontrolled COPD.

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FDA Delays Decision on Sanofi (SNY)-Regeneron Dupixent in COPD

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