After reviewing a follow-up, independent study conducted by the Duke Clinical Research Institute (DCRI), an FDA advisory panel has recommended continuing to make GlaxoSmithKline's (NYSE:GSK) type 2 diabetes drug Avandia availble to certain patients, the company announced yesterday.
Of the 26 members of a joint advisory committee to the U.S. Food and Drug Administration, 20 determined that the Risk Evaluation and Mitigation Strategy (REMS) Avandia is currently subjected to should be either modified or removed. According to Glaxo, five members of committee suggested the REMS in place for Avandia should remain, while one recommended withdrawing Avandia from the U.S. market.
In response to the findings, Glaxo chief medical officer Dr. James Shannon commented, "We continue to believe that Avandia is a safe and effective treatment option for type 2 diabetes when used for the appropriate patient and in accordance with labeling."
FDA will review both the results from an earlier independent study of Avandia, in addition to the new analysis, prior to making its final decision. Avandia will remain an alternative for doctors to prescribe to assist patients with low blood sugar as a result of type 2 diabetes.
The vote is a recommendation to the FDA and is not binding. The panel ruling is a small victory for British drugmaker Glaxo after more than a half-decade defending the safety of Avandia, which was once the best-selling diabetes drug in the world. Sales began plummeting in 2007 after researchers first raised questions about possible links to heart attacks. After three years of debate, the FDA limited access to the drug in 2010 and European regulators banned the pill altogether.
The FDA convened this week's two-day meeting to consider a new analysis of Avandia's cardiovascular safety performed by Duke University's Clinical Research Institute.
The study concluded "that the risks of mortality and major adverse cardiac events with Avandia in combination with metformin or SU are no different than with a combination of metformin and SU [without Avandia]," according to the company.
-- Material from The Associated Press was used in this report.
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