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# FDA Extends Review of Pfizer Growth Hormone
- URL: https://www.fdaweb.com/fda-extends-review-of-pfizer-growth-hormone/
- Published: 2021-09-24T12:00:00.000Z
- Updated: 2026-09-14T17:16:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150221

FDA has extended by three months the review of a Pfizer/Opko Health BLA for somatrogon, a once-weekly long-acting recombinant human growth hormone for treating growth hormone deficiency in pediatric patients. The goal date was extended to give the agency more time to review a Pfizer submission of additional data to the original BLA. The new user fee review action target date is 1/2022.

The companies describe Somatrogon as an investigational biologic product that is “glycosylated and comprises the amino acid sequence of human growth hormone and one copy of the C-terminal peptide (CTP) from the beta chain of human chorionic gonadotropin (hCG) at the N-terminus and two copies of CTP (in tandem) at the C-terminus. The glycosylation and CTP domains account for the half-life of the molecule.”