Majority of FDA panel votes in favor of Avandia

Jul 30 2007

GlaxoSmithKline has welcomed the nearly unanimous recommendation of an U.S. Food and Drug Administration's (FDA) advisory committee to support Avandia's (rosiglitazone maleate) continued availability to patients in the U.S.

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.

"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."