Avandia: FDA to restrict use, EMA recommends suspension

The FDA announced Thursday that it will significantly restrict the use of GlaxoSmithKline's Avandia (rosiglitazone) for patients with type 2 diabetes, while the European Medicines Agency recommended the suspension of the marketing authorisation for the product.

In its decision, US regulators said new prescriptions of the drug will be limited to those patients who cannot control their diabetes with other drugs and who have been briefed about the drug's cardiovascular risks. The US agency's decision follows a similar recommendation from an advisory panel in July. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, noted that "allowing Avandia to remain on the market, but under restrictions, is an appropriate response, given the significant safety concerns and the scientific uncertainty still remaining about this drug."

Meanwhile, EU regulators noted that "in view of the restrictions already in place on the use of rosiglitazone, the Committee could not identify additional measures that would reduce the cardiovascular risk." The CHMP called for the market withdrawal of the drug, echoing recommendations issued earlier this month by the Medicines and Healthcare products Regulatory Agency.

The Committee’s recommendation has been forwarded to the European Commission, and is expected to be formally endorsed within two weeks. GlaxoSmithKline said that "as a result, physicians in Europe are being advised that affected patients need to be transitioned to alternative treatment options."

Although Mehta Partners principal, Viren Mehta, said "the decisions are not surprising," he noted that the decision still represents "a significant negative both for [GlaxoSmithKline] and Avandia. It's no longer a very important product for [GlaxoSmithKline], and will become even less so." However, Mehta and other analysts noted that the decision will likely provide the drugmaker with some protection from further US lawsuits related to the product. In July, GlaxoSmithKline agreed to pay $460 million to settle approximately 10 000 lawsuits related to the drug, in addition to the $60 million to settle 700 lawsuits announced in May.

Also Thursday, the FDA ordered GlaxoSmithKline to conduct an independent assessment of the RECORD trial, after an agency official identified a number of flaws and errors that may have influenced the trial's conclusions. In addition, GlaxoSmithKline's TIDE trial, which compares Avandia to Takeda's Actos (pioglitazone) has been halted.

Commenting on the news, GlaxoSmithKline said it "continues to believe that Avandia is an important treatment for patients with type 2 diabetes and is now working with the FDA and EMA to implement the required actions." The drugmaker also said that it will voluntarily cease promotion of Avandia in all the countries in which it operates. Avandia had sales of $3 billion in 2006, but after reports of adverse cardiovascular events emerged in 2007, revenue for the drug fell, reaching $1.2 billion in 2009.

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