PRESS RELEASE: GlaxoSmithKline revises US labeling for Avandia

GlaxoSmithKline revises US labeling for Avandia

GlaxoSmithKline announced today that it is implementing changes to the US product label for Avandia® (rosiglitazone maleate), based on an extensive and thorough review by the FDA of myocardial ischemia data on Avandia, the most widely studied oral anti-diabetic medicine available.

The existing boxed warning has been revised to add the FDA’s conclusion that, while an FDA meta-analysis of short-term studies – mostly against placebo - showed an association between Avandia and an increase in myocardial ischemic events, that risk was not confirmed or excluded in three long-term clinical trials comparing Avandia against both placebo and other oral anti-diabetes medicines. The box will state that the available data on the risk of myocardial ischemia are inconclusive.

The FDA has also concluded there is insufficient information available to determine whether any oral anti-diabetic medicine reduces cardiovascular risk. The FDA has directed that the sentence - “There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with Avandia or any other oral antidiabetic drugs” - will be added as a warning on the labels of all oral anti-diabetic medicines.

The Avandia label also has been updated to add that Avandia is not recommended - though not contraindicated - for use with patients who are taking insulin or nitrates. The label summarizes the data on myocardial ischemia to help doctors continue to evaluate which patients could benefit from taking Avandia, and those for whom alternative treatment should be considered.

The changes are now included in labeling for Avandia, and will be incorporated into future revised labeling for all approved rosiglitazone-containing products, including Avandamet (rosiglitazone maleate and metformin hydrochloride), and Avandaryl (rosiglitazone maleate and glimepiride). GSK is also preparing a Medication Guide to help educate patients about potential benefits and risks and to provide other information on Avandia.

“Avandia remains a valuable medicine for most patients with type 2 diabetes, and when used according to the labeling, has a well described and appropriate safety and effectiveness profile,” said Dr. Ronald Krall, GSK Chief Medical Officer. “Given the severity of this disease and the importance of Avandia in helping patients manage their diabetes, we will continue to work with the FDA to conduct more studies about the safety and benefits of our medicine.”

As previously stated by GSK, two long-term trials in diabetic patients comparing Avandia to other oral anti-diabetic medicines show no increased risk for cardiovascular events compared to other commonly used medications, other than the well-known risk of congestive heart failure with TZDs. One trial – ADOPT - shows no increased myocardial ischemic risk compared to metformin or sulfonylurea. The interim results of a second long-term trial – RECORD - also show no increased risk of major cardiovascular events (death, heart attack and stroke) between Avandia and other medications; however, firm conclusions cannot be drawn because the trial has not yet been completed. The updated label includes data from ADOPT and RECORD plus a third long-term trial in pre-diabetic patients (DREAM). The combined analysis of these three studies show there was no increased risk of Avandia over comparatorswith regard to myocardial infarction, mortality, or other non-heart failure cardiovascular events.

GSK believes data from ongoing and future clinical trials will provide additional scientific support for both the benefit and safety of Avandia. GSK has agreed to work with the FDA to plan and carry out a clinical trial to further investigate the cardiovascular effects of Avandia.

Avandiahas been prescribed to more than seven million people over the last seven years to help them control their blood sugar levels. Importantly, Avandia has been shown to control blood sugar for longer than the most commonly used oral anti-diabetic medicines – up to five years. Long-term glycemic control is important to help prevent the serious complications of diabetes, especially microvascular complications leading to blindness, amputation and kidney failure. Avandia is an important treatment option for physicians, since two-thirds of diabetic patients suffer with uncontrolled disease and many require two or three medicines to maintain their blood sugar.

GlaxoSmithKline — one of the world’s leading research-based pharmaceutical and healthcare companies — is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For company information, visit GlaxoSmithKline on the World Wide Web at www.gsk.com [1].