Sanofi (SNY) has released an update.
Sanofi announces the FDA has extended the priority review period for Dupixent, a treatment for COPD with type 2 inflammation, by three months, with a new target action date set for September 27, 2024. No concerns about the drug’s approvability were raised, and additional efficacy analyses from pivotal trials have been submitted. The company is also pursuing regulatory approvals globally, including a positive recommendation from the European Medicines Agency.
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