(Updates shares in paragraph 2, adds details from Pfizer statement in paragraph 4 and 5)
By Leroy Leo
June 28 (Reuters) - The U.S. Food and Drug Administration has approved Pfizer Inc and partner OPKO Health Inc's treatment for growth hormone deficiency in children, the companies said on Wednesday.
The approval, which comes after an initial rejection from the FDA in January last year, lifted Pfizer's shares marginally and Opko Health's nearly 19% in premarket trading.
The injectable hormone therapy, to be sold under brand name Ngenla, was approved for the treatment of pediatric patients aged three years and older.
The once-weekly injection will be sold at a monthly list price of about $8,300, assuming a child of weight 35 kg, Pfizer said.
The comapny will also offer patients some benefits to cut their out-of-pocket costs and provide assistance programs to improve access to Ngenla, which is expected to become available in the U.S. in August.
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.
For years, daily growth hormones injections have been the standard of care. But in recent years, some drugmakers have been focusing on long-acting growth hormones to improve patient convenience.
Ngenla in a late-stage-study showed that the once-weekly injection was non-inferior compared to Pfizer's approved growth hormone Genotropin, which is for daily administration.
The FDA was initially expected to make a decision on Ngenla by October 2021 but had pushed it back by three months after Pfizer submitted some additional data on the drug.
With the latest approval of Ngenla, Pfizer will compete with Ascendis Pharma's once-weekly growth hormone injection, Skytrofa, which was approved by the FDA in 2021.
Ngenla is already approved for treatment of pediatric GHD in more than 40 markets, including Canada, Japan, and countries in Europe. (Reporting by Leroy Leo in Bengaluru; Editing by Shinjini Ganguli)