Sogroya Approved to Treat Growth Hormone Deficiency

August 28, 2020 – The U.S. FDA has approved Sogroya® (somapacitan-beco) injection 10mg/1.5mL (6.7mg/mL), manufactured by Novo Nordisk, for the replacement of endogenous growth hormone in adults who have growth hormone deficiency (GHD). It is the first human growth hormone (hGH) therapy for GHD that adult patients take only once a week. Other FDA-approved hGH formulations for this population require daily administration.

GHD is a rare disorder that can be present at birth (congenital), acquired (caused by radiation, tumors, infection, or trauma), or idiopathic (without a known cause). It occurs when the pituitary gland cannot produce enough growth hormone. When the disease manifests during childhood, it leads to slow growth, small stature, and delays in development. Adult-onset GHD can cause problems such as fatigue, osteoporosis, weakened muscles, and cardiovascular issues.

In a clinical trial, Sogroya’s effectiveness was determined based on the percentage change of truncal fat. This fat, which accumulates in the central area of the body, is regulated by growth hormone and can be associated with serious medical issues. By the end of a 34-week treatment period, patients on Sogroya achieved an average 1.06% decrease in truncal fat. Truncal fat increased by an average of 0.47% in patients on placebo and decreased an average of 2.23% in patients who received daily somatropin (a current standard of care). Patients receiving Sogroya had similar improvements in other clinical endpoints compared to those receiving daily somatropin, such as normalization of insulin-like growth factor I standard deviation scores (a measurement used to assess GHD).

Recommended initial dosing is 1.5mg once weekly, injected subcutaneously in the thigh or abdomen. The dosage should be increased every 2-4 weeks by approximately 0.5-1.5mg until the desired clinical response has been achieved. Dosage should be titrated based on clinical response and serum insulin-like growth factor 1 (IGF-1) concentrations and should not exceed 8mg once weekly. Injection sites should be rotated regularly. Dose modification may be required for patients 65 years and older, patients who have hepatic impairment, and women who are receiving oral estrogen.

Novo Nordisk has not yet announced launch or pricing plans.