Lanreotide (Somatuline): Orphan Drug for Acromegaly

SomatulineLanreotide acetate (Somatuline Depot Injection, Tercica) has been approved for the treatment of acromegaly, a rare and potentially life-threatening disease in adults. Abnormal secretion of growth hormone (GH) is commonly caused by a benign tumor in the pituitary gland.

This new treatment lowers the levels of certain hormones in the body, including GH and insulin-like growth factor. Excessive GH secretion cancauseen largement of the hands, feet, facial bones, and 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.

The safety and effectiveness of the product was determined in two pivotal clinical trials involving 400 patients.

(Source: FDA, August 30, 2007.)