The FDA Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee voted to keep the Glaxo’s diabetes medicine Avandia available to patients in the US. The FDA will review the panel’s recommendation before making a decision.
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.
GlaxoSmithKline 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 US. The company said it will continue to provide information to the FDA to assist in the Agency’s final decision-making.
“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.”
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.