U.S. Food and Drug Administration approved Sogroya (somapacitan) 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.
Adult patients with growth hormone deficiency can receive growth hormone as replacement therapy.
Most common side effects: 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, 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.
FDA granted the approval to Novo Nordisk, Inc.