FDA Extends Priority Review Deadline For Regeneron Pharmaceuticals And Sanof's Dupixent For The Treatment Of COPD Patients With Type 2 Inflammation To September 2024

Author: Benzinga Newsdesk | May 31, 2024 01:55am

The US Food and Drug Administration (FDA) has extended by three months the target action date of its priority review of the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). The revised target action date is September 27, 2024. The FDA did not raise any concerns regarding the approvability of Dupixent for this indication.

The FDA had requested additional efficacy analyses on the efficacy of Dupixent in the BOREAS and NOTUS pivotal trials. Based on the submission of these analyses earlier in May, the agency has now determined that this additional information constituted a major amendment to the sBLA and extended the target action date accordingly.

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