To print: Select File and then Print from your browser's menu

Title: FDA Approves New Avandamet (Rosiglitazone Maleate/Metformin) Dosage Strengths For Treatment Of Type 2 Diabetes

"FDA Approves New Avandamet (Rosiglitazone Maleate/Metformin) Dosage Strengths For Treatment Of Type 2 Diabetes"

New Dosage Strengths Offer Physicians and Patients Dosing Flexibility For Managing Type 2 Diabetes PHILADELPHIA, PA -- August 27, 2003 -- GlaxoSmithKline (NYSE: GSK) today announced that the U.S. Food and Drug Administration (FDA) approved new dosage strengths for Avandamet™ -- a treatment that combines two important diabetes medications in a convenient pill. The new Avandamet dosages of 1 gram metformin combined with 2 mg or 4 mg rosiglitazone will be available to patients in approximately six weeks. "GlaxoSmithKline is pleased with the FDA's approval of the new Avandamet 1 gram tablets as they will offer additional dosing flexibility for the many type 2 diabetes patients who are currently taking a total daily dose of 2 grams of metformin," said David Brand, Vice President, Metabolic/Endocrine Marketing, GlaxoSmithKline. "Over the long-term, many patients on traditional agents do not reach the American Diabetes Association (ADA) recommended goal for blood sugar control, which puts them at increased risk for diabetes-related complications such as heart disease. With Avandamet, we look to provide an effective and convenient treatment option for patients to help manage their type 2 diabetes." Avandamet was approved by the FDA in October 2002 as an adjunct to diet and exercise to improve blood sugar control in people with type 2 diabetes who are already treated with Avandia(R) (rosiglitazone maleate) and metformin as separate tablets, or who are not adequately controlled on metformin alone. In addition to the new dosages, which will be available to patients in approximately six weeks, Avandamet is currently available in three tablet strengths of rosiglitazone/metformin, respectively: 1 mg /500 mg, 2 mg/500 mg, 4 mg/500 mg. The Importance of Early and Aggressive Treatment Type 2 diabetes is characterized by high blood sugar levels that occur when the body cannot make enough insulin and/or respond normally to the natural insulin it makes (a condition called insulin resistance). In patients with type 2 diabetes, pancreatic beta cells (the cells that make and release insulin) generally start to fail over time and produce progressively less insulin. This may lead to increased blood sugar levels and progressive worsening of the disease. When blood sugar levels are elevated over an extended period of time, serious complications may result. Research shows benefits of early and aggressive treatment of type 2 diabetes. The landmark United Kingdom Prospective Diabetes Study (UKPDS) revealed that tight blood sugar control may help delay or prevent the complications of type 2 diabetes. The ADA established an A1C goal of less than 7 percent as the therapeutic target. As traditional agents often fail over time, many type 2 diabetes patients may need a combination therapy, such as Avandamet, to help achieve the ADA goal of less than 7 percent. Avandamet -- Advancements in Combination Therapy Research has demonstrated that the combination of Avandia and metformin significantly reduces and maintains blood sugar levels, compared to metformin alone. The combination therapy is associated with a low risk of hypoglycemia (low blood sugar) and offers a convenient two-in-one dosing. The concomitant use of Avandia and metformin as separate tablets was first approved by the FDA in 1999 as safe and effective based on two controlled clinical trials in people with type 2 diabetes inadequately controlled on metformin alone. Avandamet -- For Type 2 Diabetes Avandamet along with diet and exercise helps improve blood sugar control. It is a combination of two drugs -- rosiglitazone maleate and metformin HCl. A small number of people who have taken metformin, one of the components of Avandamet, have developed a rare yet serious condition called lactic acidosis (a buildup of lactic acid in the blood). Lactic acidosis occurs most often in people with kidney problems and can be fatal in up to one half of the cases. Avandamet should not be used in people with kidney problems or in people 80 years of age and older whose kidneys are not functioning properly. Avandamet should not be used by people who drink alcohol excessively or by those taking medication for heart failure. It is not approved for use with insulin. Avandamet may cause swelling, which, if left unchecked, could lead to or worsen heart failure. If people experience an unusually rapid increase in weight, swelling, shortness of breath, or have a history of these conditions, they should talk to their doctor immediately. Avandamet is not recommended for people with active liver disease. Blood tests should be conducted before and while taking Avandamet to check for liver problems. If people experience unexplained tiredness, stomach problems, dark urine or yellowing of the skin, they should talk to their doctor immediately. Women who are nursing, pregnant, thinking about becoming pregnant or premenopausal should talk to their doctor before taking Avandamet. SOURCE: GlaxoSmithKline

Copyright © 2009 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content.