The U.S. Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for review submitted by Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi (NASDAQ:SNY) for the lead drug candidate Dupixent (dupilumab) for the treatment of patients with prurigo nodularis.
The regulatory agency has assigned Priority Review for the application and set a PDUFA target action date of Sept. 30, 2022.
