GlaxoSmithKline Plc (GSK)’s Avandia, the best-selling diabetes pill that was pulled off the market in Europe and tightly restricted in the U.S. because of its heart risks, will undergo another regulatory review.
The U.S. Food and Drug Administration plans a June meeting to discuss a re-analysis of a 2009 study, known as Record, that found Avandia more than doubled the risk of heart failure, without increasing hospital stays or death from cardiovascular disease. The re-analysis was requested by a previous advisory panel that found the drug should remain available in the U.S.
Glaxo isn’t filing any new applications for Avandia or seeking wider use of the medication, Mary Anne Rhyne, a spokeswoman for the London-based drugmaker, said in a telephone interview. The results have been submitted to a journal for publication and a summary is posted on the company’s clinical trial register, she said.
“We welcome the opportunity to update the U.S. Food and Drug Administration about completion of these post-marketing requirements related to Avandia,” she said in an e-mail. “GlaxoSmithKline stands behind the safety and efficacy of Avandia when used appropriately and according to its label.”
The unusual decision to further review the data may mean the agency wants to try again to pull the drug, which once had $3 billion in annual sales, said Ira Loss, an analyst at Washington Analysis who tracks the FDA. Avandia posted a loss of $19 million last year, according to Rhyne.
“They must have something in this new adjudication that gives them more leverage,” Loss said in a telephone interview. “Very few patients are able to get the drug any more. I have no idea why they are wasting two days of an advisory committee meeting. It’s sort of like beating a dead horse.”
The study being re-analyzed was funded by Glaxo and done at the request of European regulators. The analysis was conducted by the Duke Clinical Research Institute in Durham, North Carolina, and covers 4,500 patients enrolled in the trial from 2001 through 2009, she said.
The FDA is evaluating the results of Duke’s reassessment, and it’s possible the findings could change the way Avandia is handled, said Morgan Liscinsky, an agency spokeswoman. The agency was concerned about the way the study was originally designed and conducted, thus prompting the review, she said in a telephone interview.
Glaxo, the U.K.’s biggest drugmaker, has said it paid more than $3 billion to settle federal and state government claims that it illegally marketed Avandia, once the world’s best- selling diabetes pill, and other medications. The drug is governed by a strict program in the U.S. that limits its use to patients who understand the risks and have no alternatives.
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