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FDA panel says Avandia restrictions should be eased

Vote backs wider use of GSK's drug in diabetes

FDA headquarters White Oak

After three years of restricted use, a US FDA advisory committee has voted that GlaxoSmithKline's (GSK) diabetes treatment Avandia should not only stay on the market but also be made more widely available.

The move comes on the back of an FDA report which suggested concerns about cardiovascular side effects with Avandia (rosiglitazone) - which first surfaced when the results of the RECORD trial were published  in 2009 - is lower than previously thought.

A reassessment of the RECORD data found GSK's drug was not linked to an increased risk of CV events such as heart attack, and a subsequent FDA analysis backed up that assertion. Overall, the committee agreed with the findings of the re-assessment, although some still voiced concerns about the design of the study and asked for another clinical trial to settle the matter.

Thirteen of the 26 members of the FDA's panel voted to keep Avandia on the market and also to relax the Risk Evaluation and Mitigation Strategy (REMS) programme for the drug, which was implemented in 2010. The drug was taken off the market entirely in Europe.

Seven panellists voted to remove the restrictions entirely and allow Avandia to be freely prescribed once again, while five wanted the restrictions to remain as they are and one voted to remove the drug from the market.

The REMS requires prescribers of the drug to be certified and patients to have exhausted other treatment options before Avandia can be used, and the restrictions have had a dramatic impact on prescription numbers.

An FDA spokesman told the committee that Avandia had been used in around 117,000 patients in 2009, but plummeted to just over 3,400 patients in the 2011-2013 period. That trend is also reflected in sales of the drug, which were around $3.4bn at peak but were under $10m last year, with the decline exacerbated by the loss of patent protection in 2011.

The FDA still has to decide whether it will heed the panel's advice, but has given no indication that it will do so within a specific timeframe.

While the verdict will have limited impact on Avandia's commercial prospects, it is notable that the drug was cited in a wider investigation of marketing practices by GSK which resulted in the pharma company agreeing to pay a $3bn settlement last year.  The company was accused of failing to report safety data in its promotion of the drug.

In a statement, GSK's chief medical officer James Shannon said the company will "continue to work with the FDA as it considers the recommendation of the committee," adding: "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."

Panel composition questioned?
The vote has been followed almost immediately by questions about the impartiality of the panel, however, with an article in Forbes suggestions that the membership and agenda were skewed in favour of the drug's safety.

A number of the experts who voted to restrict the drug in 2010 were not present at yesterday's meeting, says the article. Meanwhile, doubts have also been cast on the independence of the RECORD trial reassessment, with FDA reviewer Thomas Marciniak recently expressing concern that GSK sponsored the work.

7th June 2013

From: Sales, Regulatory



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