Pfizer Inc. PFE said Wednesday the U.S. Food and Drug Administration has approved its Ngenla once-weekly, human growth hormone treatment for children aged three and older who have growth failure due to inadequate secretion of endogenous growth hormone. Ngenla is expected to become available for U.S. prescribing in August. Growth hormone deficiency, or GHD, is a rare disease that affects one in about 4,000 to 10,000 children. Without treatment, children can grow to only a very short height in adulthood and puberty may be delayed. Children with GHD often suffer other physical symptoms, such as decreased muscle tone and bone density, as well as mental health issues such as anxiety and depression. The approval is based on data from a Phase 3 trial that met its primary endpoint of Ngenla non-inferiority compared to somatropin, as measured by annual height velocity at 12 months.annual height velocity at 12 months. Pfizer’s stock was slightly higher premarket, but has fallen 29% in the year to date, while the S&P 500 SPX has gained 14%.
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