FDA advisory panel votes for Avandia to be available in US

8/06/2007- GlaxoSmithKline today welcomed the nearly unanimous recommendation of an U.S. Food and Drug Administration’s (FDA) advisory committee to support Avandia’s (rosiglitazone maleate, marketed in India by GSK Pharmaceuticals as Windia) continued availability to patients in the US. The company said it will continue to provide information to the FDA to assist in the Agency’s final decision-making.

 

On July 30th, the FDA Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted that the data suggests some ischemic risk with Avandia, a treatment for type 2 diabetes. The committee declined to comment on comparative risk of Avandia to other oral anti-diabetic medicines. The committee also voted to keep the medicine available to patients in the US. The FDA will review the panel’s recommendation before making a decision.

 

Commenting on the development, Dr. Sadhna Joglekar, Vice-President, Medical Affairs & Clinical Research, GSK Pharmaceuticals India said, “We are very pleased with the outcome of the scientific deliberations of the Advisory Committee. The verdict of the Committee will ensure that Windia will continue to be available in India and provide sustained glycemic control to diabetic patients as it has in the past”.

 

“We welcome this decision as positive for patients. This was the first opportunity for these scientific experts to review the full data behind Avandia. The committee recognized the debilitating nature of this disease and the importance of multiple treatment options,” said Dr. Ronald Krall, Chief Medical Officer, GlaxoSmithKline. “Diabetes is a progressive disease that exacts a terrible toll on its victims, and it is important that Avandia remain a treatment option for patients.”