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).
Ascendis Pharma, based in Copenhagen, Denmark, announced that the company’s once-weekly TransCon Growth Hormone hit the primary endpoints in a Phase III height study in children with pediatric growth hormone deficiency.
Ferring Pharmaceuticals Inc. announced that the U.S. FDA approved Zomacton (somatropin) for Injection 5 mg and 10 mg recombinant human growth hormone (GH) indicated for replacement of GH in adults with GH deficiency.
Nine Biotechs Facing FDA Decisions in December 2017Active Psoriatic Arthritis (PsA), Biopharma, Biosimilars, Biotech, Breast Cancer, Chronic Myeloid Leukemia (CML), Contraceptives, FDA, FDA/Regulatory, Glucagon-Like Peptide-1 (GLP-1) Analogs, Growth Hormone Deficiency (GHD), Hormonal Contraceptive Patches, New Drug Application (NDA), New Drug Applications, OTC, Patches, PDUFA, Supplemental Biologics License Application (sBLA), Supplemental New Drug Application (sNDA), Supplemental New Drug Application (sNDA), Type 2 Diabetes
The biopharma industry and the U.S. Food and Drug Administration face a busy December with nine companies awaiting approval decisions.
Versartis Inc. said the company’s experimental human growth hormone somavaratan failed to meet endpoints in a critical Phase III trial.
OPKO Health Inc. said its experimental drug for GHD in adults failed to provide a statistically significant benefit over a placebo in a late-stage study.