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 The U.S. Food and Drug
Administration today approved Somatuline Depot (lanreotide acetate
injection) for the treatment of acromegaly, a rare and potentially
life threatening disease in adults caused by abnormal secretion of
growth hormone (GH), commonly from a benign tumor located in the
pituitary gland located in the brain.
"This type of therapy provides an alternative for patients who
have not responded to other therapies," said Steven Galson, M.D.,
M.P.H., director, Center for Drug Evaluation and Research. "The new
approval reflects FDA's goals for making effective and safe
treatments available to patients with rare diseases under the Orphan
Drugs program."
FDA has approved Somatuline Depot for the long-term treatment of
patients with acromegaly who have had inadequate response to or can
not be treated with surgery and/or radiation therapy. This new
treatment lowers the levels of certain hormones in the body,
including GH and insulin-like growth factor. Excessive GH secretion,
working through insulin-like growth factor, can cause enlargement of
the hands, feet, facial bones, and enlargement of 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.
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The safety and effectiveness of
Somatuline Depot (administered through injection) was determined in
two pivotal clinical trials involving a total of 400 patients.
Common side effects include diarrhea, gallstones, skin reactions
such as itching, slow heart rate, and change in blood sugar levels.
Patients with diabetes who receive treatment with Somatuline Depot
may need to have their diabetes medication adjusted.
FDA designated Somatuline Depot orphan status because the drug
treats a rare disease and meets other criteria. Orphan products are
developed to treat rare diseases or conditions that affect fewer
than 200,000 people in the United States. The Orphan Drug Act
provides a seven-year period of exclusive marketing to the first
manufacturer who obtains marketing approval for a designated orphan
product. Acromegaly affects approximately 15,000 people in the
United States and Canada and is most commonly found in middle-aged
adults. Patients with acromegaly have reduction in life expectancy
of 5 to 10 years.
The drug will be marketed by Beaufour Ipsen, Paris, France.
[Text copied
from U.S. Food and Drug Administration
news release]
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