SmithKline Beecham's Avandia (rosiglitazone maleate) received Food and Drug Administration approval for the treatment of type 2 diabetes as monotherapy and in combination with metformin. Avandia is a new thiazolidinedione (TZD), the class of oral antidiabetic agents that treat the symptoms of type 2 diabetes and directly target insulin resistance.
The FDA approval was based on a review of data from clinical studies involving more than 5,500 patients. In these studies, Avandia effectively lowered blood sugar levels of patients by up to an average of 76 mg per deciliter and maintained blood sugar control for up to 12 months. Because of its high potency, only a small dose of Avandia is needed to achieve therapeutic control (4 mg/day and 8 mg/day), SmithKline reported, noting that Avandia, which received priority review from the FDA, was well-tolerated in clinical trials.
COPYRIGHT 1999 Lebhar-Friedman, Inc.
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