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Bristol-Myers Squibb Discontinues Development of Pargluva

Posted: Tuesday, May 30, 2006

Researchers at the Cleveland Clinic found that Pargluva could double the risk of death, heart attack or strokes in diabetics compared to a placebo.

Pharmaceutical company Bristol-Myers Squibb on Thursday discontinued development of a drug for diabetes after deciding long-term trials would be needed for the drug to get regulatory approval. In October, the Food and Drug Administration asked for more information about muraglitazar, an oral treatment for Type 2 diabetes. The FDA wanted to know more about the drug's affect, if any, on cardiovascular health after clinical tests showed there could be a higher-than-acceptable occurrence of heart attacks and other adverse events.

The advocacy group Public Citizen called on the FDA to hold off approving Pargluva, saying it may raise the risk of congestive heart failure and death.

Bristol-Myers Squibb said getting the information the FDA asked for would mean long-term studies. Considering the diabetes treatment alternatives likely to be available in five years, the company decided to discontinue development of the drug.

As previously disclosed on October 18, 2005, the U.S. Food and Drug Administration 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, the company has continued to further 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.

This follows the announcement last week that AstraZeneca dropped its Dual PPAR Agonist, Galida: After analyzing results from the latest trials, involving 2,245 patients, the company said it believed it was "unlikely to offer patients significant advantage over currently available therapy". Levels of creatinine were higher for those on Galida.

This leaves only Merck’s dual PPAR agonist Arylthiazolidinedione and Naviglitizar LY519818 being developed by Ligand and Eli Lilly which is going into Phase 3 studies. Would not be suprising if they also dropped their products also.

Source: Diabetes In Control