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The Food and Drug Administration (FDA) has approved Somavert (pegvisomant) for the treatment of acromegaly, a potentially life threatening disease triggered by an excess of growth hormone. Somavert is approved for patients who have had an inadequate response to existing therapies.
"This new kind of treatment will help prevent many of the serious complications of acromegaly, by reducing the activity of the hormone whose excess causes the complications," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "Our approval reflects FDA’s goal of making safe and effective treatments to improve lives available as rapidly as possible, in this case through our critically important orphan drugs program."
Pegvisomant, the first in a new class of drugs called growth hormone receptor antagonists, normalized concentrations of IGF-I in more than 90 percent of patients by blocking the effects of growth hormone.
Acromegaly causes headaches, profuse sweating, swelling, joint disorders, changes in facial features, and enlarged hands, feet and jaw.
If untreated, patients with acromegaly often have a shortened life span because of heart and respiratory diseases, diabetes mellitus and cancer.
In clinical studies, the most commonly reported side effects with pegvisomant were injection site reactions, sweating, headache and fatigue. Patients should have tests to monitor their liver function during the first six months of therapy with pegvisomant.
Pegvisomant will be marketed as Somavert by Pharmacia Corporation of Peapack, N.J.
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