GSK's blockbuster drug Avandia reviewed

An independent advisory panel set up to advise the US Food and Drug Administration began two days of meetings Wednesday (5 June) to decide whether to urge regulators to keep restrictions on the drug, or to allow the drug to be more widely available.

Once a blockbuster drug for patients with type 2 diabetes, Avandia was approved in 1999 and soared to sales of three billion dollars per year, but its use has declined dramatically in recent years.

The experts convened by the FDA are debating a new review of the GSK trial called RECORD, which confirmed the company's initial finding that Avandia does not raise cardiac risk any more than other diabetes drugs on the market.

The British pharmaceutical company GSK recently paid researchers at Duke University in North Carolina to carry out this new analysis of the data.

Rigorous review

FDA experts said this week on the agency's web site that the Duke review was "rigorous" and "overall supports the previous observation that, in this trial, rosiglitazone was not associated with increased all-cause mortality or increased cardiovascular mortality," it said, referring to the active ingredient in Avandia.

However, other research has pointed to a rise in heart attack and stroke among patients using Avandia to control their blood sugar, and some critics have said the RECORD trial, which showed it was safe, was actually flawed.

"The uncertainty about the risk of Avandia is overwhelmingly the most important reason for the differing opinions on the regulatory actions that have been taken on this medication," said Janet Woodcock, director of FDA's Centre for Drug Evaluation and Research.

"Therefore, we have an obligation to better understand the trade-offs based on as much scientific evidence as possible," she said.

The controversy over Avandia erupted after a 2007 study in the New England Journal of Medicine found that it raised the risk of heart attack by 43%.

In 2010, the FDA slapped tight restrictions on use of Avandia, following the recommendations of independent experts who had concluded the drug significantly raised the risk of heart attacks.

A decision is expected on from the 28-member panel, and the FDA is likely to heed its findings.

Source: AFP via I-Net Bridge