FDA approves Pfizer's Ngenla for pediatric GHD

US pharma giant Pfizer (NYSE: PFE) says the US Food and Drug Administration (FDA) has approved Ngenla (somatrogon-ghla), a once-weekly, human growth hormone analog indicated for treatment of pediatric patients aged three years and older who have growth failure due to inadequate secretion of endogenous growth hormone.

Ngenla, which is being developed with OPKO Health (Nasdaq: OPK), is expected to become available for US prescribing in August 2023. The FDA had previously issued a complete response letter on the marketing application.

Growth hormone deficiency (GHD) is a rare disease characterized by the inadequate secretion of the growth hormone somatropin from the pituitary gland, affecting one in approximately 4,000 to 10,000 children.