The U.S. FDA will delay the review for a label expansion of Sanofi and Regeneron's blockbuster biologic, Dupixent, in uncontrolled chronic obstructive pulmonary disease (COPD).
According to Sanofi, the FDA had requested additional efficacy analyses on the efficacy of Dupixent in the BOREAS and NOTUS pivotal trials and the drugmaker had submitted the analyses earlier in May. Now, the agency has determined that this additional information constitutes a major amendment to the sBLA, extending the PDUFA date to September 27, 2024.
Just last week, Sanofi presented data from the phase 3 NOTUS study at a late-breaking session of the 2024 American Thoracic Society International Conference, revealing that the study confirmed the positive results demonstrated in the phase 3 BOREAS study.
Meanwhile, EMA's CHMP has recommended the approval of Dupixent as an add-on maintenance treatment for COPD.
Now a top seller for both Sanofi and Regeneron, Dupixent (dupilumab) was first approved in 2017 for eczema. It has since received subsequent approvals in asthma, rhinosinusitis, prurigo nodularis and eosinophilic esophagitis, including pediatric approvals in eczema and eosinophilic esophagitis.
Sanofi and Regeneron said they remain confident that the additional analyses support the approval of Dupixent in COPD and are committed to working with the FDA to make that happen,
