Pfizer-Opko's growth disorder drug accepted for US FDA review

The U.S. Food and Drug Administration accepted for review Pfizer Inc. and OPKO Health Inc.'s application for its experimental growth disorder drug somatrogon.

The regulator is expected to announce its decision in October 2021, Pfizer said in Jan. 4 news release.

Somatrogon is a long-acting human growth hormone, and if approved, will serve as a once-weekly treatment of pediatric patients with a growth hormone deficiency, or GHD.

GHD is a rare disorder that occurs when there is inadequate secretion of growth hormone from the pituitary gland which is located at the base of the brain.

The marketing application was backed by results from a phase 3 global trial, which showed somatrogon to be as effective as Pfizer's other growth disorder therapy Genotropin in increasing the height of children in the study.

The companies signed an agreement in 2014 to develop and commercialize somatrogon to treat GHD. Miami-based Opko Health is overseeing the clinical development of the drug and New York-based Pfizer the commercialization.

Somatrogon holds orphan drug designation in the U.S. and the EU for the treatment of children and adults with GHD, Pfizer added.