FDA delays review of Dupixent for the treatment of COPD

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).

Developed by Regeneron (Nasdaq: REGN) and marketed by French pharma major Sanofi (Euronext: SAN), the interleukin (IL)-13 and IL-4 blocking antibody. notched up sales of 10.72 billion euros ($11.59 billion) for the French drug major last year.

The revised target action date is September 27, 2024. The FDA did not raise any concerns regarding the approvability of Dupixent for this indication.