Tougher review foreseen for Glaxo diabetes drug

GlaxoSmithKline’s Avandia may face tougher scrutiny from a U.S. advisory panel reviewing whether the diabetes pill should be pulled from the market than a similar analysis in 2007, doctors said.

Avandia was linked to heart attacks and other cardiovascular complications in two new studies published Monday that the authors say should prompt U.S. regulators to block its sale. Outside advisers to the Food and Drug Administration will meet for two days beginning July 13 and are likely to consider whether the pill should remain on the market, deputy commissioner Joshua Sharfstein said.

Glaxo’s treatment, approved in 1999, generated $1.1 billion in revenue last year. The new research and the FDA’s increased focus on patient safety will make for a “politically charged” panel meeting, said Harlan Krumholz, a cardiologist and professor of medicine at Yale University.

“The growing clamor about drug safety and increasing concerns about the transparency of data and the balancing of risks and benefits are putting the FDA in the position where they’re probably a little more on the defensive” than in 2007, Krumholz said.

Almost 50,000 elderly Americans died, suffered strokes, or developed heart failure after taking Avandia instead of a rival medicine since the Glaxo treatment was approved, according to a drug-safety reviewer at the FDA who conducted one of the new studies. A second study, from the scientists who first raised the alarm about Avandia, found one of every 52 patients taking the drug was harmed.

An FDA advisory panel reviewed the drug in 2007 and “the vote was 22-1 in favor of keeping Avandia available for patients,” Glaxo spokeswoman Mary Anne Rhyne said yesterday in an e-mail. “FDA has not issued its list of questions for this meeting yet so we can’t really comment further.”

The results of the two studies, which include information gathered since Avandia was first linked to heart complications in 2007, may provide the impulse the agency needs to take action, said Steven Nissen, head of cardiology at the Cleveland Clinic in Ohio and the second study’s lead author.

The research, published in the Journal of the American Medical Association and the Archives of Internal Medicine, is part of a push by safety advocates to get Avandia taken off the market. A rival medicine, Takeda Pharmaceutical Co.‘s Actos, lowers diabetics’ blood sugar levels as well as Avandia and doesn’t raise heart attack risks, according to Nissen.

“These numbers do not reflect reality,” Rhyne, the Glaxo spokeswoman, said in an e-mailed statement. “If these numbers about Avandia were true, we would have seen them clearly in the long-term studies we have already done. None of these sources are showing adverse events even remotely comparable to these numbers.”

More than 4,000 lawsuits have been filed against Glaxo alleging Avandia causes heart attacks and strokes in some users. Glaxo in May agreed to pay $60 million in the first settlements of the litigation, people familiar with the accords said then.

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By Molly Peterson and Michelle Fay Cortez

Bloomberg News