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Update 08:49 AM EST: Adds latest share price moves
Pfizer (NYSE:PFE) and OPKO Health (NASDAQ:OPK) announced Wednesday the FDA approval of Ngenla, a once-weekly human growth hormone analog for children with growth hormone deficiency, commonly known as dwarfism.
Pfizer (PFE) shares traded flat while OPKO Health (OPK) added ~18% in reaction to the announcement.
Specifically, the FDA approval for Ngenla (somatrogon-ghla) allows its use in children aged three years and older whose growth failure is caused by insufficient production of growth hormone. The companies expect to launch Ngenla for the U.S. market in August 2023.
The approval is based on data from a Phase 3 study that reached its primary endpoint of non-inferiority for once-weekly Ngenla against once-daily somatropin.
Growth hormone deficiency is a rare disorder that is estimated to affect 4,000–10,000 children.
"As a new, longer-acting option that has the ability to reduce treatment frequency from daily to weekly," Ngenla could be important to improve medication compliance in children treated for growth hormone deficiency, pediatric endocrinologist Joel Steelman remarked.