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FDA seeks more safety data for Bristol-Myers/Merck diabetes drug
  By Jennifer Corbett Dooren
10:10 AM ET Oct. 18, 2005
WASHINGTON (MarketWatch) -- The U.S. Food and Drug Administration has requested more safety information about a proposed diabetes drug that would be marketed by Bristol-Myers Squibb Co. (BMY) and Merck & Co. (MRK), the companies said Tuesday.
Both firms said the FDA wants more information from clinical trials involving the drug, Paragluva, "to address more fully the cardiovascular safety profile."
Last month an FDA advisory panel of outside medical experts voted 8 to 1 to recommend the agency approve Pargluva despite cardiovascular concerns raised by the agency.
"The companies are eager to begin discussions with the FDA to address this issue and to determine what additional information may be necessary," the firms said in a joint statement issued Tuesday.
During last month's advisory committee meeting, the FDA said there was increase in events like heart-failure and strokes among patients in the clinical trials compared to those not receiving the drug.
Pargluva was studied in more than 3,000 patients. There were nine deaths from a cardiovascular events, but an FDA medical reviewer said the agency could not conclude the deaths were linked to the drug.
A spokesman for Bristol-Myers Squibb said there was no immediate timeframe to begin discussions with the FDA about Pargluva. Bristol-Myers and Merck filed for FDA approval of the drug in December and the agency was slated to make its decision this month.
In requesting the additional safety data, the FDA issued an "approvable" letter, meaning the drug could be approved once the agency receives and reviews the new information. Paragluva is a new type of drug that would be used to treat type II diabetes, the more common form of the disease, and if approved would be the first drug in its class.
Pargluva targets receptor cells known as PPARS, which help the body use sugar and fat. Other diabetes drugs on the market target one type of PPARS, which regulates sugar. Along with blood-sugar, Pargluva targets lipids or fat levels in the blood, partly by lowering so-called "bad" cholesterol and raising "good" cholesterol.
The FDA noted the other diabetes drugs that also target PPAR receptor cells - but do not target lipids - are also associated with "dose-related fluid retention...edema, and congestive heart failure." Those drugs are sold under the brand names Avandia by GlaxoSmithKline PLC (GSK) and Actos by Takeda Pharmaceuticals North America Inc. and Eli Lilly & Co. (LLY), were both approved in 1999.
One of the issues with Pargluva is whether the small increase in cardiovascular events was an effect of fluid-retention seen with the other PPARS diabetes drugs or "whether some other, unexpected pharmacologic effect was manifest," the FDA said during last month's advisory panel meeting on Pargluva. The agency noted that having diabetes alone increases cardiovascular risks.
Pargluva's clinical studies suggested a lower rate of problems when it was administered alone rather than in combination with other diabetes drugs already on the market. The panel voted 7 to 2 that it would be okay for Pargluva to be prescribed with metformin but voted 6 to 3 against prescribing it in combination with sulfonylurea.
About 18 million Americans have diabetes, a disease that is characterized by high blood glucose levels that result from the body's inability to use or produce insulin, which is needed to use sugar from foods. Type II diabetes is the more common form of the disease and is typically characterized by an inability to properly use insulin. It most often occurs in people who are older than 45 and overweight. Type I results from the body's inability to produce insulin and is usually diagnosed in children and young adults. Diabetes can also lead to blindness, kidney disease and puts people at higher risk for heart attacks and strokes.
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