The FDA has extended its priority review of the supplemental biologics license application (sBLA) for Dupixent as an add-on maintenance treatment in certain adult patients with uncontrolled COPD. The revised target action date is Sept. 27, 2024.
Regeneron Pharmaceuticals Inc. and Sanofi said the FDA did not raise any concerns regarding the approvability of the drug in its statement. Dupixent was originally accepted for FDA priority review in March, with a target date for a decision in June. The agency subsequently requested additional analyses of the efficacy of Dupixent back in May. Because of this, the FDA determined that the additional information constitutes a major amendment to the sBLA and has extended the target action date accordingly.
Regeneron and Sanofi are confident that the additional analyses strongly support the approval of Dupixent in COPD with evidence of type 2 inflammation and are committed to working with the FDA to bring Dupixent to patients living with uncontrolled COPD as quickly as possible.
Additionally, submissions for Dupixent in COPD are currently under review with regulatory authorities around the world, including the European Union (EU) and China. Recently, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion and recommended the approval of Dupixent as an add-on maintenance treatment in adults with uncontrolled COPD characterized by raised blood eosinophils. The potential use of Dupixent in COPD is currently under clinical development, and the safety and efficacy have not been fully evaluated by any regulatory authority.
