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FDA approved Pfizer’s once-weekly human growth hormone analog for treatment of growth failure in pediatric patients.
FDA announced approval of Pfizer’s NGENLA (somatrogon-ghla), a once-weekly human growth hormone analog, on June 28, 2023. Somatrogon-ghla is approved as a treatment for pediatric patients aged three and older who have growth failure, also known as growth hormone deficiency (GHD), due to inadequate secretion of endogenous growth hormone.
According to a Pfizer press release, FDA based its approval on a multi-center randomized, open-label, active-controlled Phase III study evaluating the safety and efficacy of somatrogon-ghla when administered once-weekly, relative to once-daily somatropin. The study met its primary endpoint of somatrogon-ghla non-inferiority compared to somatropin, as measured by annual height velocity at 12 months. Additionally, it was generally well tolerated and had a safety profile comparable to somatropin.
GHD is a rare disease characterized by inadequate secretion of somatropin, a growth hormone, from the pituitary gland. Without treatment, children will have persistent growth attenuation, a very short height in adulthood, and delayed onset of puberty. According to the release, it’s estimated to affect approximately one in 4000 to 10,000 children.
“For more than 30 years, Pfizer has been committed to supporting children and adults living with growth hormone deficiency, beginning with the delivery of a medicine that has long been a part of the standard of care,” said Angela Hwang, chief commercial officer, president, Global Biopharmaceuticals Business, Pfizer, in the release. “We are excited to bring this next-generation treatment to patients in the United States, continuing our commitment to helping children living with this rare growth disorder reach their full potential.”