FDA review of GSK's Avandia continues

The FDA has announced it will continue its review of the GSK's diabetes drug Avandia, saying it will not be rushed into any action. In what is proving to be a tough week for GSK, the move comes just days after the FDA included the company's blockbuster drug Advair as one of four asthma treatments that should be used less often by patients.

On Monday we reported that the pharmaceutical company had been battling to defend its asthma drug Advair after the US Food and Drug Administration (FDA) had announced that long-acting beta agonists (LABAs) ould never be used alone in the treatment of asthma. at the end of last week, the FDA ordered that manufacturers now include a warning on product labels, giving manufacturers just 30 days to respond to the proposed changes.

Now, while they are already fighting this - having been among the first of drug makers to speak out against the changes - the agency has today issued a statement after two US senators - Max Baucus and Chuck Grassley - released details a Senate Finance committee report based on a two-year inquiry of GSK's diabetes treatment Avandia (rosiglitazone).

According to the statement, the committee report was prompted by the publication of a study in the New England Journal of Medicine in May 2007, which warned of the possible cardiovascular risk of the drug. In addition, the report contains a memo from two FDA drug safety officals who recommend that Avandia be withdrawn from the market as they believe it is more dangerous than Takeda's rival treatment Actos.

Warning

Already, Avandia carries a boxed warning which which states that rosiglitazone in patients with established Class III or IV heart failure is contraindicated and is not recommended in patients with symptomatic heart failure.

However, while the senators have attacked the FDA for not making changes, the agency says it is happy for the time-being. Instead the FDA has announced that it has been following a number of observational studies, and will present "the totality of new and existing cardiovascular safety data" on Avandia at a joint public meeting of the Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees in July 2010.

In the meantime, GSK is standing firmly behind the drug, stating that "the scientific evidence simply does not establish that Avandia increases ischemic cardiovascular risk".

Matthew Buttell

Matt Buttell graduated from Bath Spa University in 2006. Since then he has written for several publications, before moving to the web. He now writes solely for the internet, continuing to cover key business issues while managing his own personal blog.

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