PargluvaTreatment for Diabetes Type 2
Bristol-Myers Squibb Statement on Muraglitazar, an Investigational Oral Treatment For Type 2 Diabetes
PRINCETON, N.J., October 27, 2005 -- As previously disclosed, on October 18, 2005, the U.S. Food and Drug Administration (FDA) issued an approvable letter for muraglitazar, Bristol-Myers Squibb Company's investigational oral medicine for the treatment of type 2 diabetes. The FDA requested additional information from ongoing clinical trials to more fully address the cardiovascular safety profile of muraglitazar. We and our partner, Merck & Co., Inc., (Merck) have determined that to receive regulatory approval and to achieve commercial success, additional studies may be required because the ongoing trials were not designed to answer questions raised by the FDA. The additional studies could take approximately five years to complete.
In addition, Bristol-Myers Squibb has agreed to begin discussions with Merck to terminate the collaborative agreement.
Bristol-Myers Squibb will continue discussions with the FDA and will consider a range of options including conducting additional studies or terminating further development of muraglitazar.
Source: Bristol-Myers Squibb
Posted: October 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 and Merck Joint Statement on FDA Advisory Committee Vote on Pargluva (Muraglitazar), an Investigational Oral Treatment for Type 2 Diabetes - September 9, 2005
- Bristol-Myers Squibb Provides Regulatory Update for Muraglitazar - December 23, 2004