FDA panel votes to modify GSK Avandia restrictions

June 6, 2013 | By Márcio Barra

After two days of deliberation, an FDA advisory panel voted today that the severe restrictions (REMS) placed on rosiglitazone (Avandia, sold by GlaxoSmithKline), which limited its use to only 3000 patients, are to be modified. The Internet is booming with reactions, so I’ll leave here two great articles on the subject – Matthew Herper’s Liveblog of the FDA advisory committee deliberation and Larry Husten’s excellent summing up article. It’s worth noting that the main beneficiary here will not be GSK but Teva Pharmaceuticals, which has a generic version. The press release provided by GlaxoSmithKline is avaliable after the click.

GSK statement in response to FDA Advisory Committee’s vote on availability of Avandia (rosiglitazone)

Issued: Thursday 06 June 2013, Philadelphia, PA

GlaxoSmithKline [NYSE: GSK] confirmed today that a joint advisory committee to the U.S. Food and Drug Administration (FDA) voted to continue to make Avandia(rosiglitazone) available to appropriate patients with the majority of the members voting to either modify (13) or remove (7) the Risk Evaluation and Mitigation Strategy (REMS) program in place. Remaining members voted to continue the REMS (5) or withdraw (1) Avandia from the US market.

The committee discussion overall reflected confidence in the integrity and reliability of RECORD. The independent re-examination of RECORD was conducted by the Duke Clinical Research Institute (DCRI) and confirmed the study’s original findings: 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].

“We appreciate the committee’s thorough examination of the RECORD results and will continue to work with the FDA as it considers the recommendation of the committee,” said Dr. James Shannon, GSK’s Chief Medical Officer.“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 labelling.”

The recommendation of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee will now 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.

In the re-examination, DCRI not only analyzed the RECORD results under the original study protocol, but also used the latest revised definitions now under development by the FDA. Regardless of the analyses employed, the DCRI findings confirmed the original findings.

About GlaxoSmithKline

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. For further information please visit http://us.gsk.com/

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