As previously disclosed, on October 18, 2005, the US Food and Drug Administration 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.
The company and its 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, states a company.
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.
Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.