FDA grants priority review for Dupixent in COPD, sets June approval decision deadline
Sanofi and Regeneron’s megablockbuster Dupixent just got one step closer to a landmark approval.
The FDA has granted a priority review with a target deadline of June 27 for an approval decision on Dupixent for a subset of chronic obstructive pulmonary disease patients, the drugmakers said Friday. If approved, it would be the first biologic to treat that form of COPD, a space where other pharma efforts have stumbled, like AstraZeneca’s Fasenra and GSK’s Nucala.
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