Large Cardiovascular Outcomes Study To Be Initiated
Manufacturing Comparability Analysis Complete: Exenatide Once Weekly NDA Submission Remains On Track
SAN DIEGO, INDIANAPOLIS, and CAMBRIDGE, Mass., March 26 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced that a meta-analysis of primary cardiovascular events across controlled clinical studies of three months or greater, from the BYETTA(R) (exenatide) injection database, showed no increased risk of cardiovascular events associated with exenatide use. This analysis was done in a manner consistent with U.S. Food and Drug Administration's (FDA's) updated guidance for evaluating cardiovascular risk in type 2 diabetes agents. Results of this analysis indicate that the relative risk of cardiovascular events in exenatide-treated patients, compared to controls, was 0.70 with a 95 percent confidence interval of 0.38 - 1.31. In this analysis, cardiovascular events included cardiovascular mortality, myocardial infarction, stroke, hospitalization for acute coronary syndrome and revascularization procedures. This finding suggests there is no increased risk of exenatide on cardiovascular outcomes and will be used to support the cardiovascular safety of exenatide once weekly, a phase 3 investigational formulation of exenatide, the active ingredient in BYETTA.
To determine if there are favorable cardiovascular effects of exenatide treatment, Lilly and Amylin intend to initiate a large cardiovascular outcomes trial with a superiority design that will evaluate the effects of exenati
|SOURCE Amylin Pharmaceuticals, Inc.|
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