The joint advisory committee to the FDA has voted to continue to make Avandia (rosiglitazone; GlaxoSmithKline) available to appropriate patients with the majority of the members voting to either modify (13 votes) or remove (7 votes) the Risk Evaluation Mitigation Strategy (REMS) program in place.
Five members voted to continue the REMS and one voted to withdraw Avandia from the market. Three of the twelve panelists who voted to remove Avandia from the market in 2010 were also present at the meeting.
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The discussion centered on the re-examination of the RECORD trial conducted by the Duke Clinical Research Institute (DCRI). Their analysis supported the study’s original findings that the risks of mortality and major adverse cardiac events with Avandia in combination with metformin or sulfonylurea are no different than with a combination of metformin and sulfonylurea.
According to the New York Times, panel member Rebecca Killion said: “Our charge here is to be cautious, but an overabundance of caution is not a neutral position. It can actually be detrimental to patients. Our charge here is to be safe, but to be sane.”
Avandia is a thiazolidinedione indicated as adjunct to diet and exercise in type 2 diabetes, as monotherapy, or in combination with metformin and/or a sulfonylurea. Under the current REMS, Avandia can be used only as last resort if patients have failed previous therapy. Also, it is only available at certain pharmacies, and doctors and patients must acknowledge the risks involved.
GlaxoSmithKline lost market exclusivity for Avandia in 2011 when its patent expired. Teva Pharmaceuticals has the approval to market a generic version, but has yet to produce a product.
The recommendation of the Endocrinology and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will be considered by the FDA in making its final decision.
Pending the FDA’s decision, Avandia will be available through the REMS program to physicians and appropriate patients as an option to help control blood sugar in patients with type 2 diabetes.
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