PargluvaTreatment for Diabetes Type 2
Bristol-Myers Squibb and Merck Joint Statement on FDA Advisory Committee Vote on Pargluva (Muraglitazar), an Investigational Oral Treatment for Type 2 Diabetes
PRINCETON, N.J. and WHITEHOUSE STATION, N.J., September 9, 2005 -- 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 (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.
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."
Posted: September 2005
- Bristol-Myers Squibb Statement on Muraglitazar, an Investigational Oral Treatment For Type 2 Diabetes - October 27, 2005
- Bristol-Myers Squibb and Merck Joint Statement on Regulatory Status of Pargluva (Muraglitazar), an Investigational Oral Treatment for Type 2 Diabetes - October 18, 2005
- Bristol-Myers Squibb Provides Regulatory Update for Muraglitazar - December 23, 2004