Monday, September 12, 2005

Merck, BMS' Pargluva recommended for approval by FDA advisory committee

Merck, BMS' Pargluva recommended for approval by FDA advisory committee

A Food and Drug Administration advisory committee voted 8-1 in favor of approving Bristol-Myers Squibb Co. and Merck & Co. Inc.'s oral Pargluva (muraglitazar) as a monotherapy for treating type 2 diabetes, Dow Jones Newswires reported.

The panel also voted 7-2 in favor of the drug being used in combination with metformin, but voted 6-3 against its use in combination with sulfonylurea drugs.

The Endocrinologic and Metabolic Drugs Advisory Committee was convened to discuss potential cardiovascular risks associated with the drug, which, if approved, would be the first in a new class of drugs called glitazars.

Pargluva studies were conducted in more than 3,000 patients and nine cardiovascular deaths were observed, Dow Jones reported, adding that an FDA reviewer said "the agency could not conclude the deaths were linked to the drug."

Panel member Dr. Thomas Aoki, an endocrinologist at the University of California at Davis, said he thought the potential risks could be monitored and managed, according to Dow Jones. An example he gave was that if patients rapidly gained weight as a result of fluid retention, they should call their physician and be taken off the drug.

Additionally, the FDA noted that just having diabetes increases a person's risk for cardiovascular problems and that other peroxisome proliferator-activated receptor drugs for diabetes are also associated with "dose-related fluid retention ... edema and congestive heart failure," according to Dow Jones.

If Pargluva is approved, Merck and BMS plan to conduct additional studies on the potential cardiovascular risks, Dow Jones stated.

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