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WASHINGTON, Sep 12, 2005 (United Press International via COMTEX) -- A government advisory panel has backed approval of a new drug for Type 2 diabetics, despite concerns the drug may cause dangerous or fatal cardiovascular side effects in some patients.
At the same time, the panel recommended that the Food and Drug Administration disallow use of the drug in combination with another common diabetes drug because of safety issues.
The drug, called Pargluva, would become the third in a class of medications widely used by patients with Type 2, or insulin-resistant diabetes. A fourth related drug, Rezulin, was pulled from the market in 2000 because of evidence it caused liver damage.
The drug works by enhancing the sensitivity to insulin that diabetics lack, helping them gain long-term control of their blood sugar.
FDA usually follows the advice of its advisory panels, but is not bound to do so.
If approved by the agency, Pargluva is projected to bring marketers Bristol-Myers Squibb and Merck & Co. a total of about $950 million in annual sales by 2008, David Moskowitz, a pharmaceutical analyst with Friedman Billings Ramsey in Arlington, Va., told United Press International.
Type 2 makes up the vast majority of the estimated 18 million cases of diabetes in the United States. The disease is a common consequence of obesity, and it can lead to a host of serious health problems, including kidney failure, heart disease and blindness.
At the panel's meeting last Friday, Pargluva's sponsors showed several studies concluding that the drug can reliably lower blood glucose levels, a goal physicians consider the most important factor in avoiding the consequences of diabetes. Long-term glucose control is measured on a scale called hemoglobin A1c.
Fifty-eight percent of patients taking 2.5 mg of the drug and 72 percent of patients taking 5 mg of the drug for 24 weeks achieved A1c levels below 7, the target recommended by the American Diabetes Association.
"This is an important result for those patients whose blood glucose can be more difficult to control," Dr. Cindy Rubin, a Bristol-Myers researcher, told the panel.
The panel voted 8 to 1 to back Pargluva as a drug to be taken on its own, despite 16 deaths in patients taking the drug either alone or in combination with other treatments during clinical trials. The companies reported 33 serious cardiovascular events, including heart attacks and strokes, in 225 patients taking 5 mg or less per day. Nine of the deaths were from cardiovascular causes, they said.
Most of the deaths were confined to two of six clinical studies, throwing into question the drug's safety in the real world of medical practice. Company officials said they have committed to an extensive adverse events study if the drug is allowed in the U.S. market.
The study assuaged the concerns of many of the panel members, several of whom suggested they would not support Pargluva's approval without ongoing vigilance by the manufacturer.
"I still think its too equivocal and the signs are too great, said Susanna L. Cunningham, a professor of behavior nursing at the University of Washington in Seattle and the panel's consumer representative.
"The entire public would be exposed to the drug while the trial is going on," said Cunningham, the sole member of the panel to vote against approval.
Other members said Pargluva was safe enough to go on the market now, but they would be watching closely for longer term results from the company.
"This drug is being brought forward as a way of reducing cardiovascular mortality, then the patients who seem to be at the highest risk of cardiovascular mortality don't do very well with the drug," said Dr. Nelson B. Watts, the panel's chairman. "I think the sponsor has sufficient plan to address this issue."
The panel also voted 6 to 3 to reject approval of Pagluva when combined with sulfonylurea, another popular diabetes drugs sold under the names Amaryl and Glucotrol. The vote stemmed from results of a trial showing the combination leads to an unacceptably high level of side effects.
The vote could restrict sales of Pargluva if and when it comes on the market, Moskowitz said.
"Sulfonylureas are a large part of the diabetes market," he said. Given that combining the two drugs may be contra-indicated by regulators, "that could limit the market potential," he added.
Earlier last week, the same panel recommended approval of a first-ever inhaled version of insulin, which if approved could allow diabetics to take their short-acting medication without injections.
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Todd Zwillich covers healthcare policy for UPI. E-mail: sciencenews@upi.com
Copyright 2005 by United Press International.
