SNY - FDA Extends Review Deadline For Regeneron/Sanofi's Dupixent For 'Smoker's Lungs' Disease | Benzinga
On Friday, the FDA extended the target action date of priority review of supplemental application seeking approval for Dupixent (dupilumab) as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD), a lung disease that’s usually caused by smoking.
The revised target action date is September 27, 2024. The FDA accepted the application in February, with a target action date of June 27, 2024.
The FDA did not raise any concerns regarding the approvability of Dupixent for this indication.
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