Panel Recommends Muraglitazar for the Treatment of Type 2 Diabetes
Sep 10, 2005 - 10:26:38 PM
Bristol-Myers Squibb and Merck & Co., Inc. jointly announced today that the U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee voted to recommend approval of PARGLUVA(TM) (muraglitazar), the companies' 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.
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.
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.
"Bristol-Myers Squibb and Merck are encouraged by this recommendation," said Elliott Sigal, M.D., Ph.D., chief scientific officer and president, Pharmaceutical Research Institute, Bristol-Myers Squibb. "We are committed to bringing important medicines to patients with type 2 diabetes and look forward to further discussions with the FDA."
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