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news.An FDA advisory committee has voted to recommend approval of Pargluva, an oral medicine for the treatment of type 2 diabetes co-developed by Bristol-Myers Squibb and Merck & Co.
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The drug reduces glucose levels in the blood, and also increases levels of high-density lipoprotein, or ‘good’ cholesterol.
Pargluva is an investigational oral medication that, if approved, would become the first marketed agent in a new class of compounds called glitazars. It is a dual alpha/gamma PPAR (peroxisome proliferator-activated receptor) activator.
Activation of PPAR-gamma is associated with reductions in glucose levels in the blood, while activation of PPAR-alpha is associated with reductions in plasma triglyceride levels and increases ‘good’ cholesterol levels.
Bristol-Myers Squibb and Merck are collaborators in the global development and commercialization of Pargluva. The new drug application for Pargluva was submitted to the FDA in late December 2004.
“Bristol-Myers Squibb and Merck are encouraged by this recommendation,” said Dr Elliott Sigal, chief scientific officer and president of the Pharmaceutical Research Institute at 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.”