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FDA approval to weekly therapy for adult growth hormone deficiency
The U.S. Food and Drug Administration approved Sogroya (somapacitan) on August 28 for adults with growth hormone deficiency. Sogroya is the first human growth hormone (hGH) therapy that adult patients only take once a week by injection under the skin; other FDA-approved hGH formulations for adults with growth hormone deficiency must be administered daily.
Growth hormone deficiency is a disorder characterized by inadequate growth hormone production from the anterior pituitary gland, a small gland located at the base of the brain that produces several hormones. Adult patients with growth hormone deficiency can receive growth hormone as a replacement therapy.
Sogroya was evaluated in a randomized, double-blind, placebo-controlled trial in 300 patients with growth hormone deficiency who had never received growth hormone treatment or had stopped treatment with other growth hormone formulations at least three months before the study. Patients were randomly assigned to receive injections of weekly Sogroya, weekly placebo (inactive treatment), or daily somatropin, an FDA-approved growth hormone. The effectiveness of Sogroya was determined by the percentage change of truncal fat, the fat that is accumulated in the trunk or central area of the body that is regulated by growth hormone and can be associated with serious medical issues.
At the end of the 34-week treatment period, truncal fat decreased by 1.06%, on average, among patients taking weekly Sogroya while it increased among patients taking the placebo by 0.47%. In the daily somatropin group, truncal fat decreased by 2.23%. Patients in the weekly Sogroya and daily somatropin groups had similar improvements in other clinical endpoints.
The most common side effects of Sogroya include: back pain, joint paint, indigestion, a sleep disorder, dizziness, tonsillitis, swelling in the arms or lower legs, vomiting, adrenal insufficiency, hypertension, increase in blood creatine phosphokinase (a type of enzyme), weight increase, and anemia.
Sogroya should not be administered to patients with a history of hypersensitivity (allergy) to the drug. Sogroya should also not be used in patients with active malignancy, any stage of diabetic eye disease in which high blood sugar levels cause damage to blood vessels in the retina, acute critical illness, or those with acute respiratory failure, because of the increased risk of mortality with use of pharmacologic doses of Sogroya in critically ill patients without growth hormone deficiency.
Health care providers should perform an eye examination before starting Sogroya, and periodically thereafter, to exclude pre-existing papilledema (a condition in which there is swelling in the optic nerve at the back of the eye). Papilledema (swelling of the optic nerve) may be a symptom of intracranial hypertension (increased pressure inside the skull). Growth hormones may induce or worsen pre-existing intracranial hypertension.
FDA granted the approval to Novo Nordisk, Inc.
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