Key Points
June 28 (Reuters) - The U.S. Food and Drug Administration has approved Pfizer Inc (PFE.N) and partner OPKO Health Inc's (OPK.O) treatment for growth hormone deficiency in children, the companies said on Wednesday...
The injectable hormone therapy, to be sold under brand name Ngenla, was approved for the treatment of pediatric patients aged three years and older..
Growth hormone deficiency is a rare disease that affects one in about 4,000 to 10,000 children, and is characterized by inadequate secretion of the growth hormone, resulting in very short height in adulthood and delayed puberty without treatment...
Pfizer's Ngenla in a late-stage-study showed that the once-weekly injection was non-inferior compared to the company's approved growth hormone Genotropin, which is for daily administration...
With the latest approval of Ngenla, Pfizer will compete with Ascendis Pharma's (A71.F) once-weekly growth hormone injection, Skytrofa, which was approved by the FDA in 2021...
