Pfizer Inc. said on January 21 the U.S. health regulator declined to approve somatrogon as a treatment for growth hormone deficiency in children that the company developed with partner Opko Health Inc.
The U.S. Food and Drug Administration approved Ascendis Pharma’s Skytrofa (lonapegsomatropin-tcgd) for children 1 year and older who have growth failure from inadequate secretion of endogenous growth hormone (GH).
Pfizer and OPKO Health are one step closer to receiving approval for their jointly developed pediatric growth hormone deficiency drug somatrogon after the U.S. Food and Drug Administration accepted the companies’ Biologics License Application (BLA) for the therapy.
Pfizer and Opko Health reported their Phase III clinical trial of somatrogan met the primary endpoint compared to Genotropin (somatropin) for treating children 3 to 18 years of age with growth hormone deficiency (GHD).