FDA Approves Pfizer’s Human Growth Hormone Drug

On June 28, Pfizer announced that the U.S. Food and Drug Administration (FDA) approved their human growth hormone analog, NGENLA. They anticipate the drug becoming available for prescription in August 2023 in the U.S. 

Following its approval for the treatment of growth hormone deficiency in patients aged three or older, the pharmaceutical company expressed its enthusiasm for making the treatment available to patients in the U.S. What sets NGENLA (somatrogon-ghla) apart from existing treatments is a longer period of action. Which allows a longer period between administrations, going from daily injection treatments to a once-a-week treatment. 

Related Article: Pfizer’s RSV Vaccine Gets FDA Approval for Use in Older Adults

A Breakthrough in Growth Hormone Deficiency Treatment 

NGENLA is a human growth hormone analog that is administered via injection just below the skin. Its function is to compensate for the deficiency of growth hormone in the body. Growth hormone deficiency (GHD) is a disease characterized by insufficient production of growth hormone in the body. GHD can be congenital or acquired, and it can occur during infancy or childhood. It affects about one in every 4,000 to 10,000 children. Symptoms of the condition include slow growth, short stature, and delayed or absent sexual development. 

NGENLA was developed as a result of a worldwide agreement between Pfizer and the healthcare company, OPKO. Per their agreement, OPKO was responsible for conducting the clinical program, and Pfizer was responsible for the registration and commercialization of the drug. OPKO’s chairman and chief executive officer, Phillip Frost, M.D., said, “We are proud of the clinical development program that supported the FDA approval of NGENLA and are excited about its potential for these patients and their families as it becomes available in the United States.”

Empowering patients with Improved Treatment 

The FDA’s approval follows the positive results displayed by the drug in its phase 3 study. During which its safety and efficacy were studied when administered once a week. NGENLAN was compared to the established GH analog somatropin and met its primary endpoint. The study showed equivalent safety profiles between the two therapies, proving that NGENLA was not less effective than the daily injection of somatropin. 

The introduction of this new treatment to the U.S. market is an important improvement for children with growth hormone deficiency. Its long-acting characteristic simplifies treatment and enhances patients’ experiences. The reduction in treatment burden is especially important for the children, as it presents an easier to follow regime.

Author

GeneOnline Team