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# Pfizer/OPKO Pediatric Growth Hormone OK’d
- URL: https://www.fdaweb.com/pfizer-opko-pediatric-growth-hormone-okd/
- Published: 2023-06-28T12:00:00.000Z
- Updated: 2026-09-14T18:41:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154790

FDA has approved a Pfizer and OPKO Health BLA for Ngenla (somatrogon-ghla), a once-weekly, human growth hormone analog indicated for treating pediatric patients (three years of age and older) who have growth failure due to inadequate secretion of endogenous growth hormone.

Approval is based on data from a Phase 3 study comparing the drug to once-daily somatropin, according to Pfizer. “The study met its primary endpoint of Ngenla non-inferiority compared to somatropin, as measured by annual height velocity at 12 months,” it says. “Ngenla was generally well tolerated in the study and had a safety profile comparable to somatropin.”