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FDA considers lifting safety limits on diabetes drug Avandia



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— Withdrawing the drug from the market entirely

At the last FDA meeting on Avandia in 2010, the panelists voted 21 to 12 to leave Avandia on the market. The group’s recommendations are not binding and are only one part of the government’s decision-making process.

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Even if the latest reassessment clears Avandia’s safety record, the real-world impact could be minimal.

Avandia is currently prescribed to just 3,000 patients in the U.S. In 2009 the drug was prescribed 2.7 million times.

Because of FDA restrictions put in place in 2010, patients can now only get the drug after signing a waiver from their doctor indicating that they understand the risks and have tried all other drug options to treat their disease.

Glaxo executives say they believe the drug should remain available for patients with hard-to-treat diabetes, but the company has no plans to resume advertising of the drug.

"I think there are patients who benefit from this drug and I would hope the committee continues to allow Avandia to be prescribed to the right patients," said Glaxo vice president Murray Stewart.

Stewart stressed that Glaxo did not request the panel meeting, which was set up by the FDA.

"We were phoned up earlier in the year and told they were having an advisory meeting and that GSK should present," Stewart said.

Wall Street analysts have dubbed the meeting a "non-event" from a financial perspective, since Glaxo’s stock price long ago absorbed the impact of the Avandia controversy.


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Last July Glaxo plead guilty to failing to report safety problems with Avandia to government officials over a seven-year period. The guilty plea was part of a larger $3 billion settlement with the Department of Justice for various criminal and civil violations involving 10 Glaxo drugs.

In November, the company paid $90 million to settle allegations from 38 state governments that the company misrepresented the risks of Avandia.

The company has also settled tens of thousands of personal injury lawsuits filed by Avandia patients, though it has never specified the exact number. Last month there were 3,750 cases pending before U.S. District Court Judge Cynthia Rufe in Philadelphia, where various Avandia cases from around the country have been consolidated.

U.S. shares of GlaxoSmithKline PLC rose 64 cents to $52.41 in midday trading Monday. They traded as high as $54 last Tuesday and are up almost 25 percent from their 52-week low of $41.68 last November.



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