Somatuline Depot (lanreotide acetate injection), FDA-approved for Treatment of Acromegaly

Filed in archive FDA Approvals on September 2, 2007

[photo credit: faqs.org]

Acromegaly is a 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.

Just recently, the FDA has approved a new drug for the treatment of acromegaly: Somatuline Depot (lanreotide acetate injection) - in patients who have had inadequate response to or can not be treated with surgery and/or radiation therapy.

Somatuline Depot - a product of Tercica Inc. and will be marketed by Beaufour Ipsen (Paris, France) - works by lowering 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.]

Somatuline Depot have been designated an orphan status by the FDA because it treats a rare disease.

According to Steven Galson, M.D., M.P.H., director, Center for Drug Evaluation and Research:

"This type of therapy provides an alternative for patients who have not responded to other therapies. The new approval reflects FDA's goals for making effective and safe treatments available to patients with rare diseases under the Orphan Drugs program."

Approximately, acromegaly affects 15,000 people in the United States and Canada. This condition is most commonly found in middle-aged adults and those who have it are 5 to 10 years reduced of their life expectancy.

Source: FDA News