Latebreakers: Orphan drug acromegaly treatment wins FDA approval

September 17, 2007

Somatuline Depot receives FDA approval for the treatment of acromegaly.

Lanreotide acetate injection (Somatuline Depot, Beaufour Ipsen/ Tercica) has been approved by the FDA for the long-term treatment of acromegaly, a disease characterized by abnormal secretion of growth hormone. The drug works by lowering levels of growth hormone and insulin-like growth factor-1, which stimulate bone and tissue growth and lead to enlargement of hands, feet, internal organs, and facial bones in patients with the disease. Lanreotide is administered as a subcutaneous injection once every four weeks for three months and will be available as 60-, 90-, and 120-mg prefilled syringes in about eight weeks, according to the manufacturer. The new treatment is indicated for patients who have not responded well to or are not candidates for surgery and/or radiotherapy.