Somatuline Depot, a New Drug for Treatment of Acromegaly, Approved by FDA
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.
According to the press release, "the safety and effectiveness of Somatuline Depot (administered through injection) was determined in two pivotal clinical trials involving a total of 400 patients"
This new treatment of acromegaly with lanreotide acetate (Somatuline Depot) lowers the levels of certain hormones in the body, including GH and insulin-like growth factor.
Somatuline Depot has been given an orphan status by the FDA since this drug treats a rare disease. Orphan products are developed to treat rare diseases or conditions that affect fewer than 200,000 people in the United States. A seven-year period of exclusive marketing to the first manufacturer who obtains marketing approval for a designated orphan products is given under the Orphan Drug Act. The drug will be marketed by Beaufour Ipsen, Paris, France.
A 30-min video about acromegaly can be seen here.
Sources:
FDA Approves New Drug to Treat Rare Disease, Acromegaly. FDA Press Release.
URL: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01692.html
Somatuline® Depot becomes the first product originating from Ipsen's R&D to be approved by the FDA and marketed globally. Press Release. URL: http://www.ipsen.com/?page=mediacenter&content=pressreleases&filename=20070831___us_ma_somatuline.xml
Video: Unmasking the Mystery of Acromegaly. URL: http://www.itvisus.com/programs/hbhm/episode_803acromagaly.asp
Published by R. Bourne, Ph.D.
Ph.D. Food and Nutrition. MBA. R. Bourne writes mainly about Health and Wellness, Alternative Medicine and Healing, Nutrition, Dieting and Food Science and Technology. He has been writing online content... View profile
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