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# Pfizer/OPKO Complete Response on Growth Hormone
- URL: https://www.fdaweb.com/pfizer-opko-complete-response-on-growth-hormone/
- Published: 2022-01-21T12:00:00.000Z
- Updated: 2026-09-14T17:29:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5150980

FDA has issued Pfizer and OPKO Health a complete response letter for their BLA for somatrogon, an investigational once-weekly long-acting recombinant human growth hormone for treating growth hormone deficiency (GHD) in pediatric patients. Pfizer says it is evaluating the agency’s comments to determine an appropriate path forward.

In September, FDA extended its review of the BLA by three months to review additional data from Pfizer. 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.”

Earlier this week, the product was approved by Japanese regulators for the long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone. In 2021, Health Canada, and Australia approved it for the same indication.