Pfizer and OPKO Get FDA Approval for Childhood Growth Hormone Deficiency Treatment

OPKO Health and Pfizer’s Ngenla, a treatment for childhood growth hormone deficiency, has received approval by the US Food and Drug Administration (FDA). The treatment for the rare disease, which causes short stature and delayed puberty, had been rejected once by the agency with a request for more information.

According to , “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.

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(Source: ET Healthworld, June 28^th, 2023)