FDA withdraws restrictions on GSK's Avandia

In a too little, too late scenario, the FDA did a hard about-face today on GlaxoSmithKline's ($GSK) diabetes drug Avandia. The agency decided that the drug presents no more heart risk than the most commonly used Type 2 diabetes drugs and said it is withdrawing the label warnings and other restrictions imposed three years ago on the drug, warnings that had squelched the drug's chances in the marketplace.

It is hard to know what the new rules could mean for the drug, given that generics are available and patients have been warned away from Avandia and similar drugs for so long.

The agency said Monday that it "determined that recent data for rosiglitazone-containing drugs, such as Avandia, Avandamet, Avandaryl, and generics, do not show an increased risk of heart attack compared to the standard Type 2 diabetes medicines metformin and sulfonylurea." The FDA said that while some uncertainty still exists, "our concern is substantially reduced and the rosiglitazone REMS program requirements will be modified."

The move followed a two-day advisory board meeting in June in which the panel recommended easing restrictions on the drug after a reevaluation of the 2009 study that had said the drug carried twice the risk of heart attack of other products. In a mixed series of votes, 13 members of the advisory panel supported modifying the restrictions, while 7 panelists voted to remove all restrictions. Five others recommended keeping the restrictions on the drug as-is and one voted to withdraw Avandia from the market completely, like it has been in Europe.

Of course, GSK always stood behind the safety of the drug. Today it said in a statement: "GSK welcomes the decision of the FDA and appreciates the Agency's robust review of the science with regard to Avandia. GSK maintains its view that Avandia is a safe and effective treatment for Type 2 diabetes when used appropriately. The company will work with the FDA to update labeling and to implement the Agency's decisions regarding easing restrictions on the medicine."

The FDA said that in addition to easing the labeling it will no longer require that patients on Avandia and similar drugs be enrolled in a Risk Evaluation and Mitigation Strategy (REMS) program, that had restricted the use of rosiglitazone medicines. It said doctors can now prescribe it along with diet and exercise to control blood sugars in patients with Type 2 diabetes, and manufacturers will be getting the word out about the changes.

What this may mean for the drug at this point is hard to tell. Avandia had been a top-selling blockbuster for GSK with about $3.2 billion in 2006 revenues, Reuters says, before it was pulled from the market in Europe and had the tight restrictions placed on its use in the U.S. in 2010. Those steps were taken in large part because of the possibility of increased risk of heart attacks and strokes outlined in the RECORD study, a study that the FDA said this summer it had doubts about. The drug had sales of only about $9.7 million last year. 

Dr. Robert Tamler told Reuters that patients are unlikely to embrace these drugs now. "The decision by the FDA is irrelevant in clinical practice," said Tamler, who is director of the Mount Sinai Diabetes Center in New York. "Patients have been reading about increased risk of cardiovascular events with rosiglitazone since 2007 and will not abandon their concerns overnight, despite the FDA decision."

- here's the FDA announcement
- read the Reuters story