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Ngenla FDA Approval History

Last updated by Judith Stewart, BPharm on June 30, 2023.

FDA Approved: Yes (First approved June 27, 2023)
Brand name: Ngenla
Generic name: somatrogon-ghla
Dosage form: Injection
Company: Pfizer Inc.
Treatment for: Pediatric Growth Hormone Deficiency

Ngenla (somatrogon-ghla) is a long-acting human growth hormone analog used for the treatment of pediatric growth hormone deficiency.

  • Ngenla is indicated for treatment of pediatric patients aged 3 years and older who have growth failure due to inadequate secretion of endogenous growth hormone.
  • Ngenla is a newer, longer-acting treatment for pediatric growth hormone deficiency that provides the option to reduce the frequency of injections from once-daily to once-weekly.
  • Pediatric growth hormone deficiency is a rare disease characterized by the inadequate secretion of growth hormone from the pituitary gland, which may result in growth attenuation, short height in adulthood, and delayed puberty. Pediatric growth hormone deficiency can be caused by genetic mutations or acquired after birth.
  • Ngenla works to treat pediatric growth hormone deficiency by replacing the lack of growth hormone in the body.
  • Ngenla is administered by subcutaneous injection once weekly, on the same day each week.
  • Warnings and precautions associated with Ngenla include severe hypersensitivity reactions, decreased insulin sensitivity, intracranial hypertension, fluid retention, hypoadrenalism, hypothyroidism, development of slipped capital femoral epiphysis, progression of preexisting scoliosis, pancreatitis, and lipoatrophy.
  • Common adverse reactions include injection site reactions, nasopharyngitis, headache, pyrexia, anemia, cough, vomiting, hypothyroidism, abdominal pain, rash, and oropharyngeal pain.

Development timeline for Ngenla

Jun 28, 2023Approval FDA Approves Ngenla (somatrogon-ghla) Long-Acting Once-Weekly Treatment for Pediatric Growth Hormone Deficiency
Jan 21, 2022Pfizer and OPKO Provide Update on the Biologics License Application for Somatrogon for Pediatric Growth Hormone Deficiency
Sep 24, 2021Pfizer and OPKO Announce Extension of U.S. FDA Review of Biologics License Application of Somatrogon for Pediatric Growth Hormone Deficiency
Jan  4, 2021US FDA Accepts Regulatory Submission from Pfizer and OPKO for Review of Somatrogon to Treat Pediatric Patients with Growth Hormone Deficiency
Oct 21, 2019OPKO and Pfizer Announce Positive Phase 3 Top-Line Results for Somatrogon, an Investigational Long-Acting Human Growth Hormone to Treat Children with Growth Hormone Deficiency

Further information

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