The Food and Drug Administration has approved the first once-weekly injection to treat adult growth hormone deficiency. Somapacitan (Sogroya) is a long-acting human growth hormone. Previously, the only treatment for this condition was daily injections of human growth hormone (somatropin).
Growth hormone deficiency in adults is secondary to permanent damage to the pituitary gland, which may have occurred in childhood or as an adult. The damage is most frequently from a pituitary tumor or from treatment for the tumor. Patients with growth hormone deficiency have an increase in abdominal fat and a decrease in muscle mass, leading to reduced muscle strength and exercise capacity. Psychologically, these patients may also experience more depressed mood and anxiety.
Somapacitan was evaluated in a randomized, double-blind, placebo-controlled trial of 300 patients who had never received growth hormone or who had stopped receiving hormone injections at least three months prior to the study. Study participants received either somapacitan, placebo, or daily somatropin, the current standard treatment. At the end of the 34-week trial, truncal fat decreased by an average of 1.06% for those taking somapacitan, increased by 0.47% for those on placebo, and decreased by 2.23% for those using standard daily dosing of somatropin.
The most common adverse effects of somapacitan include back pain, joint pain, indigestion, sleep disorder, dizziness, tonsillitis, edema of the extremities, vomiting, adrenal insufficiency, hypertension, elevated blood creatine phosphokinase, weight increase, and anemia.
Somapacitan should not be given to those with active malignancy, any stage of diabetic eye disease, acute critical illness, or acute respiratory failure. NPs should perform an eye examination before prescribing somapacitan and periodically thereafter, as the drug may exacerbate or cause papilledema.
For complete prescribing information for somapacitan, see https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761156s000lbl.pdf.