Regeneron : FDA Extends Review Period For Dupixent As COPD Treatment By Three Month

(RTTNews) - The U.S. Food and Drug Administration has extended by three months the target action date of its priority review of the supplemental Biologics License Application or sBLA for Dupixent (dupilumab) as an add-on maintenance treatment in certain adult patients with uncontrolled chronic obstructive pulmonary disease or COPD, Regeneron Pharmaceuticals Inc (REGN) and Sanofi said in a statement.

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 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.

Regeneron and Sanofi said they are confident that the additional analyses strongly support the approval of Dupixent in COPD with evidence of type 2 inflammation.

Additionally, submissions for Dupixent in COPD are currently under review with regulatory authorities around the world, including the European Union 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.

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