Somatuline Depot, a New Drug for Treatment of Acromegaly, Approved by FDA

In a press release, The U.S. Food and Drug Administration announced the approval of a new drug, Somatuline Depot, (lanreotide acetate injection) for the treatment of acromegaly, a rare and potentially life threatening disease.

Acromegaly is caused by high levels of secretion of growth hormone (GH). The most common cause of this increased level of GH secretion is a benign hGH producing tumor derived from a distinct type of cells called pituitary adenoma. In a few patients, acromegaly is caused not by pituitary tumors but by tumors of the pancreas, lungs, and adrenal glands.

Acromegaly is a rare, hard to diagnose disease in the early stages because of insidious pathogenesis and slow progression. Frequently, acromegaly is missed for many years.

Symptoms of this rare disease include: soft tissue swelling of the hands and feet, brow and lower jaw protrusion, enlarging hands, enlarging feet, arthritis and carpal tunnel syndrome

teeth spacing increase, enlarged tongue, heart failure, kidney failure, diabetes mellitus

hypertension, enlarging heart, increased palmar sweating and sebum production over the face (seborrhea).

Medical imaging (MRI focussing on the sella turcica sector of the brain) and medical laboratory investigations (including TSH (thyroid stimulating hormone), gonadotropic hormones (FSH, LH), ACTH (adrenocorticotropic hormone), and prolactin) are generally used together to confirm or rule out the presence of this condition.

If untreated, patients with acromegaly often have a shortened life span because of heart and respiratory diseases, diabetes mellitus, and colon cancer. Surgery is the most effective treatment for this rare disease. However, when surgery is not possible two medications wer availabl euntil now: bromocriptine and octreotide (Sandostatin).

FDA is approving Somatuline Depot for the long-term treatment acromegaly's patients with who have had inadequate response to or can not be treated with surgery and/or radiation therapy.