FDA Approves Pfizer Human Growth Hormone Analog

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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.

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“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.”

Source: Pfizer