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FDA Advisory Committee Recommends Muraglitazar for the Treatment of Type 2 Diabetes as Monotherapy and in Combination With Metformin
Bristol-Myers Squibb researchers presented the available pre-clinical and clinical data to support the benefit-risk profile of Pargluva and reviewed a comprehensive pharmacovigilance 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.
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."
Source: Bristol-Myers Squibb and Merck & Co., Inc.