FDA Delays Dupixent Decision for COPD by Three Months, EMA Recommends Approval

1. FDA Delay: The FDA has extended the target action date for Dupixent's priority review by three months, setting the new PDUFA date for September 27, 2024.
2. EMA Recommendation: The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has given Dupixent a favorable opinion, recommending its use as an add-on treatment in adults with uncontrolled COPD.
3. Additional Analyses: The FDA requested additional analyses on Dupixent's efficacy in the Phase III Boreas and Notus trials, which led to the delay.
4. Trial Results: The Boreas and Notus trials showed significant reductions in moderate or severe acute COPD exacerbations, with a 30% drop in the Boreas trial and a 34% drop in the Notus trial.
5. Regulatory Submissions: Submissions for Dupixent in COPD are under review with regulatory authorities worldwide, including the European Commission.
6. Dupixent Sales: In the first quarter of 2024, Dupixent sales generated $3.08 billion, a 24% increase from Q1 2023.