Pfizer Says Its NGENLA Gets FDA Approval To Treat Pediatric Growth Hormone Deficiency

(RTTNews) - Biopharmaceutical major Pfizer Inc. (PFE) and OPKO Health Inc. (OPK) announced on Wednesday that the FDA has approved NGENLA, a weekly once human growth hormone analog to treat pediatric growth hormone deficiency in children three years and older.

The drug will become available in the United States for prescription in August of this year, the company said in a statement.

NGENLA has already been approved in 40 markets including Canada, Australia, Japan, and EU Member States for the treatment of pediatric GHD.

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

Without treatment, children have persistent growth attenuation, a very short height in adulthood, and puberty maybe delayed.

In premarket activity, shares of Pfizer are trading at $36.52 up 0.27% or $0.10 on the New York Stock Exchange. Shares of OPK are trading at $2.19 up 31.93% on the Nasdaq.