The U.S. Food and Drug Administration has approved Somatuline Depot (lanreotide acetate injection) for the treatment of acromegaly, a rare and potentially life threatening disease in adults caused by abnormal secretion of growth hormone (GH), commonly from a benign tumor located in the pituitary gland located in the brain.
"This type of therapy provides an alternative for patients who have not responded to other therapies," said Steven Galson, M.D., M.P.H., director, Center for Drug Evaluation and Research. "The new approval reflects FDA's goals for making effective and safe treatments available to patients with rare diseases under the Orphan Drugs program."
FDA has approved Somatuline Depot for the long-term treatment of patients with acromegaly who have had inadequate response to or can not be treated with surgery and/or radiation therapy. This new treatment lowers the levels of certain hormones in the body, including GH and insulin-like growth factor. Excessive GH secretion, working through insulin-like growth factor, can cause enlargement of the hands, feet, facial bones, and enlargement of internal organs such as the heart and liver. If untreated, patients with acromegaly often have a shortened life span because of heart and respiratory diseases, diabetes mellitus, and colon cancer.