The U.S. Food and Drug Administration (FDA) has extended the target action date for the priority review of the supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) by three months, according to a statement from Regeneron Pharmaceuticals Inc. (REGN) and Sanofi. This extension moves the revised target action date to September 27, 2024. Importantly, the FDA did not express any concerns about the approvability of Dupixent for this particular indication.
The extension was triggered by the FDA's request for additional analyses on the efficacy of Dupixent in the BOREAS and NOTUS pivotal trials. Following the submission of these additional analyses in May, the FDA classified the new information as a major amendment to the sBLA, prompting the adjusted target action date.
Regeneron and Sanofi maintain that the supplemental analyses robustly support the approval of Dupixent for chronic obstructive pulmonary disease (COPD) with evidence of type 2 inflammation.
Globally, the sBLA for Dupixent in COPD is also under review by other regulatory authorities, including those in the European Union and China. Recently, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion and recommended the approval of Dupixent as an add-on maintenance treatment for adults with uncontrolled COPD characterized by elevated blood eosinophils.
It's important to note that the potential use of Dupixent in COPD is currently in clinical development, and its safety and efficacy have yet to be fully evaluated by any regulatory authority.
For more health news, visit rttnews.com.
