Benzinga | Sep 24, 2021 04:25PM EDT

Pfizer and OPKO Announce Extension of U.S. FDA Review of Biologics License Application of Somatrogon for Pediatric Growth Hormone Deficiency

Pfizer Inc. (NYSE:PFE) and OPKO Health Inc. (NASDAQ:OPK) announced today that the U.S. Food and Drug Administration (FDA) has extended the review period for the Biologics License Application (BLA) for somatrogon, a once-weekly long-acting recombinant human growth hormone, for the treatment of growth hormone deficiency (GHD) in pediatric patients. The Prescription Drug User Fee Act (PDUFA) goal date has been extended by three months to January 2022, as a result of Pfizer's submission of additional data to the original BLA.

In 2014, Pfizer and OPKO entered into a worldwide agreement for the development and commercialization of somatrogon for the treatment of GHD. Under the agreement, OPKO is responsible for conducting the clinical program and Pfizer is responsible for registering and commercializing the product for GHD.