GSK confirms FDA advisory committees' vote to allow Avandia to remain on the market

GlaxoSmithKline (NYSE: GSK) confirmed today that a joint advisory committee to the U.S. Food and Drug Administration (FDA) voted to allow Avandia to remain on the market. Committee members voted for recommendations ranging from making no changes to the current label, to revising the label with additional warnings and restrictions to withdrawal from the U.S. market.  

"Following today's recommendations, we will, of course, continue to work with the FDA in the best interest of diabetes patients who face this chronic and serious disease," Dr. Ellen Strahlman, GSK's Chief Medical Officer, said.  "Patients taking Avandia should speak with their physician about their treatment and any questions they may have regarding the safety of the medicine."

The recommendation of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will now be considered by the FDA in making its final decision.  Pending the FDA's decision, Avandia remains available to physicians and appropriate patients as an option to help control blood sugar in patients with type 2 diabetes.

Strahlman continued:  "GSK is dedicated to sharing data about its medicines transparently and in a timely manner.  We remain fully committed to maintaining best practice disclosure of clinical data to serve the interests of regulators, physicians and patients."

Avandia is one of the most extensively researched diabetes medicines and has been studied in more than 50,000 patients.  The company has consistently shared data with the FDA and worked with the agency to update the label for Avandia as new data became available.

GSK's view remains that controlled clinical trials are the most rigorous form of scientific evaluation that can be used to assess the benefits and risks of medicines.  Results from six controlled clinical trials have been reported since the FDA last reviewed questions about the cardiovascular safety of Avandia in 2007.  Together, these trials show that Avandia does not increase the overall risk of heart attack, stroke or death.  As a result, we believe that when used in the appropriate patient and in accordance with labeling, Avandia is a safe and effective treatment option for type 2 diabetes.

"We would like to acknowledge the efforts made by the FDA to apply scientific rigour to the debate and understanding of the benefit-risk profile of Avandia," Strahlman concluded.