On October 18, 2005, the FDA issued an approvable letter for muraglitazar requesting additional information on the drug's cardiovascular safety profile. The company determined that in order to receive regulatory approval and to achieve commercial success for muraglitazar, further long-term studies to clarify the cardiovascular profile of the compound may be needed.
Since that time, Bristol-Myers Squibb has furthered its understanding of the compound and the regulatory path forward. This included additional analyses of existing studies with muraglitazar, results of outcomes studies with other PPAR alpha and gamma agonists, and the evaluation of the cardiovascular safety results from a recently-completed muraglitazar study. Based on these accumulated data, the company believes that a long-term trial is needed to achieve regulatory success.
“Based on this assessment, the company's commercial evaluation of other diabetes alternatives likely to be available in five years and consideration of competing development opportunities in the company's portfolio, Bristol-Myers Squibb has decided to discontinue the compound's development,” the company said in a statement.