PRINCETON, NEW JERSEY and WHITEHOUSE STATION, NEW JERSEY (October 18, 2005) -- Bristol-Myers Squibb Company (NYSE: BMY) and Merck & Co., Inc. (NYSE: MRK) jointly announced today that the U.S. Food and Drug Administration (FDA) issued an approvable letter for Pargluva™ (muraglitazar), the companies' investigational oral medicine for the treatment of type 2 diabetes. The FDA has requested additional safety information from ongoing trials, or those completed since the safety data from the last formal regulatory submission, to address more fully the cardiovascular safety profile of Pargluva. The companies are eager to begin discussions with the FDA to address this issue and to determine what additional information may be necessary.
In early September, Bristol-Myers Squibb researchers presented the pre-clinical and clinical data to support the benefit-risk profile of Pargluva to the FDA's Endocrinologic and Metabolic Drugs Advisory Committee.
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.
Source: Bristol-Myers Squibb Company and Merck & Co., Inc.