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This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Merck drops Pargluva partnership: Additional trials needed to support approval of Bristol-Myers Squibb's Pargluva (muraglitazar) type 2 diabetes treatment prompt Merck to drop out of its co-development partnership with BMS. Bristol remains in discussions with FDA about what clinical studies would be required to settle questions about the cardiovascular safety of the dual peroxisome proliferator-activated receptor agonist. Merck and Bristol announced FDA's "approvable" action, based on cardiovascular safety concerns, on Oct. 18. The firms subsequently determined that approval and commercial success would require additional trials that could take up to five years. Pargluva is not the first PPAR agent to succumb to safety issues: Novo Nordisk/Dr. Reddy's ragaglitazar and Merck/Kyorin's MK-0767 were discontinued in 2003 in Phase III due to animal carcinogenicity findings, and AstraZeneca pushed back a planned Galida (tesaglitazar) NDA to 2007 to gather longer-term safety data (1Pharmaceutical Approvals Monthly July 2005, p. 24)…
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