FDA Approves Ngenla (somatrogon-ghla) Long-Acting Once-Weekly Treatment for Pediatric Growth Hormone Deficiency
Pfizer Inc. and OPKO Health Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Ngenla (somatrogon-ghla), a once-weekly, human growth hormone analog indicated for treatment of pediatric patients aged three years 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 2023.
Ngenla (somatrogon-ghla) is a human growth hormone that works by replacing the lack of growth hormone in the body. Ngenla is taken by injection just below the skin, administered via a device that allows for titration based on patient need. Compared to the growth hormone, GENOTROPIN (somatropin), its action in the body lasts longer, enabling weekly injections instead of daily.
Growth hormone deficiency (GHD) is a rare disease characterized by the inadequate secretion of the growth hormone somatropin from the pituitary gland, affecting one in approximately 4,000 to 10,000 children. Without treatment, children will have persistent growth attenuation, a short height in adulthood, and puberty may be delayed. Children living with GHD may also experience challenges in relation to their physical health and mental well-being.
The most common side effects of any prescription drug are gastrointestinal issues, including nausea, constipation, and diarrhea, because most drugs go through the digestive system to be absorbed. Other common effects include drowsiness, pain, and skin reactions. Serious side effects associated with Ngenla may include:
- Fluid retention.
- Glucose intolerance and diabetes mellitus.
- Hypoadrenalism.
- Hypothyroidism.
- Increased mortality in patients with acute critical illness.
- Increased risk of neoplasm.
- Intracranial hypertension.
- Progression of preexisting scoliosis.
Ngenla is approved for the treatment of pediatric GHD in more than 40 markets including Canada, Australia, Japan, and EU Member States.
