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May 19, 2006
By: Tim Wright
Editor-in-Chief, Contract Pharma
Bristol-Myers Squibb has discontinued the development of muraglitazar, a dual alpha/gamma PPAR (peroxisome proliferator-activated receptor) agonist in development for type 2 diabetes and will focus its efforts on other priority portfolio projects. On October 18, 2005, the FDA issued an approvable letter for muraglitazar requesting additional information on the drug’s cardiovascular safety profile. Since that time, the company has continued to further its understanding of the compound. 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 contends that a long-term trial is needed. BMS’s commercial evaluation of other diabetes alternatives likely to be available in five years, as well as consideration of competing development opportunities in the company’s portfolio, led it to discontinue the compound’s development.
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