US FDA clears Ipsen drug for rare growth disorder

(Adds marketing partner, details on studies, background, FDA quote)

WASHINGTON, Aug 30 (Reuters) - U.S. health officials have approved an Ipsen (IPN.PA) drug for treating a rare and potentially life-threatening disease called acromegaly, the Food and Drug Administration said on Thursday.

The injectable drug, Somatuline Depot, was cleared for long-term treatment of patients with acromegaly who have had an inadequate response to, or cannot be treated with, surgery or radiation therapy.

Tercica Inc. TRCA.O holds U.S. marketing rights to the drug.

Acromegaly is a rare disease caused by abnormal secretion of growth hormone, commonly from a benign tumor in the pituitary gland. One of the most common symptoms of is the abnormal growth of the hands and feet.

About 15,000 people in the United States and Canada have acromegaly.

If untreated, patients often have a shortened life span because of heart and respiratory diseases, diabetes and colon cancer, the FDA said.

Somatuline Depot lowers the levels of certain hormones in the body.

The company studied the drug in two clinical trials involving 400 patients. Common side effects included diarrhea, gallstones, skin reactions, slow heart rate and changes in blood sugar levels, the FDA said.

"This type of therapy provides an alternative for patients who have not responded to other therapies," Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research, said in a statement. (Reporting by Lisa Richwine)