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

Issued: June 6, 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.

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Cautionary statement regarding forward-looking statements
GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2012.

 

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