Biotech/Pharmaceuticals

Return to Article

Pargluva Backed as Standalone Diabetes Treatment

TSC Staff

An advisory panel of the Food and Drug Administration voted to recommend market clearance for Pargluva as a standalone treatment for diabetes. The drug was codeveloped by Bristol-Myers Squibb(BMY Quote) and Merck(MRK Quote).

Despite concerns about the drug's effect on the heart, members of the FDA's Endocrincal and Metabolic Drugs Advisory Committee voted 8-1 to recommend approval of Pargluva as a way to control blood sugar in diabetics, Bloomberg said.

The disease afflicts about 18 million Americans.

The panel recommended against approving Pargluva as a combination treatment with most other diabetes treatments.

As is the case with other diabetes drugs, studies showed that Pargluva could increase the risk of heart failure in patients taking it. The drug is part of a class called dual peroxisome proliferators-activator receptor agonists, or PPAR, that are also believed to reduce the fat-like substances known as lipids in the blood stream.

The FDA isn't bound by its advisory committee reports, but it usually takes them.

Recently, shares of Bristol-Myers were up 31 cents, or 1.3%, to $25.19. Merck, which issued a long-winded elucidation of its legal strategies for Vioxx earlier, was down 14 cents, or 0.5%, to $29.05.