The approval for the drug, which comes after an initial rejection from the USFDA in January last year, lifted Pfizer’s shares marginally and Opko Health over 27 per cent 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. It is expected to become available in the U.S. in August, the companies said.
The companies did not immediately respond to Reuters request to comment on the pricing of the drug.
Growth hormone deficiency is a rare disease that affects one in about 4,000 to 10,000 children, and is characterised 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.
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.
Next 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.
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