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| |  FDA Approves Avandia For Type II Diabetes PHILADELPHIA, PA -- May 26, 1999 -- The United States Food and Drug Administration has approved SmithKline Beecham's and Bristol-Myers Squibb’s Avandia(R) (rosiglitazone maleate) for the treatment of type II diabetes as both monotherapy and in combination with metformin. Avandia is a new thiazolidinedione (TZD), a class of novel, oral antidiabetic agents that treat the symptoms of type II diabetes and directly target insulin resistance - an underlying cause of the disease. Type II diabetes affects an estimated 15 million Americans and 110 million people world-wide and can lead to devastating complications such as heart disease, blindness, kidney failure and limb amputation. "This is an important advance in the treatment of type II diabetes and offers new hope for people living with this disease," said Harold Lebovitz, M.D., professor of medicine in the division of endocrinology and metabolism/diabetes at the State University of New York Health Science Center in Brooklyn. "Unlike most traditional diabetes drugs, Avandia helps the body's own insulin work more effectively, resulting in significant blood sugar control." A fundamental problem in type II diabetes is not a lack of insulin, but rather the body's failure to respond properly to its own insulin -- known as insulin resistance. Most older type II diabetes medicines work by increasing insulin production in the pancreas or decreasing glucose output through the liver, whereas Avandia sensitises the body to use its own natural insulin more effectively. The FDA approval was based on a review of data from clinical studies involving more than 5,500 patients with type II diabetes. In these studies, Avandia effectively lowered blood sugar levels of patients by up to an average of 76 milligrams per decilitre, as compared to placebo, and maintained blood sugar control for up to 12 months. Patients achieved an average reduction in Hemoglobin A1C (HbA1C) levels up to 1.5 percentage points at a daily dose of 8 mg, demonstrating a statistically significant improvement in glycemic control relative to placebo and also in comparison to baseline. HbA1C levels reflect average blood sugar levels during the preceding two to three months. In addition, because of its high potency, only a small dose of Avandia is needed to achieve therapeutic control (4 mg/day and 8 mg/day). "People with type II diabetes need safe and effective treatments that can be used early in the disease to lower and control blood sugar levels," said James Gavin III, M.D., Ph.D., senior scientific officer of the Howard Hughes Medical Institute in Chevy Chase, MD., and past president of the American Diabetes Association. "Avandia's significant impact on blood sugar control and its ability to target insulin resistance makes it a powerful weapon in the fight against this chronic and serious condition." Avandia was well-tolerated in clinical trials. Commonly reported side effects with Avandia were upper respiratory tract infections and headaches. As observed with other members of this class of drugs, weight gain has also been reported. Additionally, anemia and edema have been reported in patients taking Avandia. There have been no reported cases of drug-related jaundice or liver failure in any Avandia clinical studies. Diabetes, which is the sixth highest cause of death by disease in the United States, strikes an estimated 16 million Americans -- 90 to 95 percent of whom have type II diabetes. Type II diabetes is one of the most costly health problems in America due to its devastating complications. It is the leading cause of adult blindness, kidney failure and non-traumatic limb loss in the United States. Diabetes is a chronic disease characterised by high blood sugar levels that result from defects in the body's ability to use and/or produce insulin. There are two main types of diabetes: type I and type II. People with type I diabetes are usually diagnosed when they are children or young adults. In type I diabetes, the pancreas makes little or no insulin, so patients must test their blood sugar and inject insulin every day. In type II diabetes, the pancreas continues to produce insulin, but the body inefficiently uses the insulin. Many patients with type II diabetes will eventually require insulin injections. The FDA placed Avandia on a six-month priority review schedule. The FDA grants priority review to drugs that, if approved, would be a significant improvement compared to currently marketed products.
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