FDA Delays Dupixent Decision for Uncontrolled COPD Treatment, EU Panel Recommends Approval

- The FDA has delayed its decision on Dupixent (dupilumab) for the treatment of uncontrolled COPD by three months, moving the target date to September 2024.
- The delay is due to the FDA's need for additional efficacy data from pivotal trials.
- Despite the delay in the U.S., the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has given a positive recommendation for Dupixent's approval in the EU for COPD.
- Regeneron and Sanofi remain confident in the drug's potential, citing strong evidence of its effectiveness in treating COPD.
- The delay in the FDA's decision contrasts with the expedited progress in the EU, where approval is expected soon.