Sogroya FDA Approval History

Last updated by Judith Stewart, BPharm on July 18, 2023.

FDA Approved: Yes (First approved August 28, 2020)
Brand name: Sogroya
Generic name: somapacitan-beco
Dosage form: Injection
Company: Novo Nordisk
Treatment for: Adult Human Growth Hormone Deficiency, Pediatric Growth Hormone Deficiency

Sogroya (somapacitan-beco) is a human growth hormone analog used for the treatment of people with growth hormone deficiency (GHD).

• Sogroya is indicated for:
  - the replacement of endogenous growth hormone in adults with growth hormone deficiency.
  - the treatment of growth failure due to inadequate secretion of endogenous growth hormone in pediatric patients aged 2.5 years and older.
• Deficiency of growth hormone in adults occurs when the pituitary gland fails to produce enough growth hormone resulting in a syndrome characterized by decreased muscle mass and exercise capacity, increased visceral fat, unfavorable alterations in lipid profile and markers of cardiovascular risk, decrease in bone mass and integrity, and increased mortality.
  Deficiency of growth hormone in children occurs when there is inadequate secretion of endogenous growth hormone resulting in short stature and an increased risk for other growth-associated problems.
• Sogroya contains a human growth hormone analog called somapacitan-beco, which works by triggering the release of another hormone in the liver called insulin-like growth factor-1 (IGF-1), which can help to maintain normal growth and metabolism.
• Traditional growth hormone treatments had to be taken every day. Sogroya is a newer once weekly, long acting treatment that leverages albumin-binding prolongation technology to prolong the half life and duration of action, and delay excretion into the urine.
• Sogroya is administered by subcutaneous injection into the upper arms, thigh, abdomen, or buttocks once weekly at any time of the day.
• Warnings and precautions include severe hypersensitivity reactions, increased risk of neoplasm, decreased insulin sensitivity, intracranial hypertension, fluid retention, reduced serum cortisol levels, hypothyroidism, pancreatitis, lipohypertrophy/lipoatrophy at the injection site, and slipped capital femoral epiphysis and progression of preexisting scoliosis in pediatric patients.
• Common side effects in adult patients with GHD include back pain, arthralgia, dyspepsia, sleep disorder, dizziness, tonsillitis, peripheral edema, vomiting, adrenal insufficiency, hypertension, increased blood creatine phosphokinase, increased weight, and anemia.
  Common side effects in pediatric patients with GHD include nasopharyngitis, headache, pyrexia, pain in extremity, and injection site reactions.

Development timeline for Sogroya

Further information

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