FDA Advisory Committee OKs PARGLUVA(TM) (muraglitazar)

The FDA has approved the investigational oral medicine for the treatment of type 2 diabetes, for use as monotherapy and in combination with metformin.

The committee voted not to recommend its use in combination with a sulfonylurea. Bristol-Myers Squibb researchers presented the available pre-clinical and clinical data to support the benefit-risk profile of PARGLUVA and reviewed a comprehensive pharmaco vigilance plan and outcomes evaluation in order to allow the therapeutic balance of PARGLUVA to be continually assessed going forward.
The FDA is not bound by the committee’s recommendation.

PARGLUVA is an investigational oral medication that, if approved, would become the first marketed agent in a new class of compounds called glitazars.
PARGLUVA is a dual alpha/gamma PPAR (peroxisome proliferator-activated receptor) activator. Activation of PPAR-gamma is associated with reductions in plasma glucose levels, while activation of PPAR-alpha is associated with reductions in plasma triglyceride levels and increases in high-density lipoprotein, or "good" cholesterol (HDL-C) levels.

FDA reviewers said Pargluva’s 2.5 milligram and 5 milligram doses were shown to control sugar levels. A lower dose — 1.5 milligrams — was also effective, although they are not seeking to market it.

Studies also showed side effects may be worse than with similar drugs, which include Actos, and Avandia.

Like similar drugs, Pargluva caused fluid retention that can lead to congestive heart failure, the FDA staff said. While overall incidence of heart failure with the drug was low, it was higher than rates found with placebo or rival medicines, they said. Pargluva’s heart risks also appeared to rise with higher doses, reviewers said.
Bristol-Myers Squibb and Merck are collaborators in the global development and commercialization of PARGLUVA. The New Drug Application (NDA) for PARGLUVA was submitted to the FDA in late December 2004.

If the FDA follows the advice, which it usually does, Pargluva would be the first approved diabetes drug that aims to lower blood glucose as well as blood lipids

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