Sanofi (NASDAQ:SNY) has received notice from the US Food and Drug Administration (FDA) that the target action date for the priority review of Dupixent (dupilumab) has been extended by three months.

The supplemental Biologics License Application (sBLA) for Dupixent, proposed as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD), will now have a revised target action date of September 27, 2024.

The extension follows the FDA's request for additional analyses on the efficacy of Dupixent from the BOREAS and NOTUS pivotal trials.

Responding to this, Sanofi and Regeneron submitted the required analyses earlier in May, which the FDA recognized as a major amendment to the sBLA, necessitating additional review time.

Importantly, the FDA has not raised any concerns regarding the approvability of Dupixent for this indication.

Sanofi and Regeneron remain confident that the additional data provided strongly supports the approval of Dupixent for treating COPD with evidence of type 2 inflammation.

They are committed to working closely with the FDA to make Dupixent available to patients with uncontrolled COPD as swiftly as possible.