Meta-analysis finds no increased risk of cardiovascular events for Byetta

Eli Lilly, Amylin and Alkermes reported Thursday that results from a meta-analysis demonstrated that there was no increased risk of cardiovascular events associated with the use of diabetes drug Byetta (exenatide). The companies said the data will be used to support the cardiovascular safety profile of the once-weekly version of the drug, Byetta LAR, which is "on track" for submission to the FDA by the end of the second quarter.

The meta-analysis involved the examination of data from clinical trials lasting three months or longer, taken from Byetta's injection database, for occurrences of cardiovascular mortality, myocardial infarction, stroke, hospitalisation for acute coronary syndrome and revascularisation procedures. The drugmakers noted that the analysis "was done in a manner consistent with [the FDA's] updated guidance for evaluating cardiovascular risk in type 2 diabetes agents." Nonetheless, Citi analyst Yaron Werber suggested "it is not clear if the FDA will accept the argument that cardiovascular analysis for Byetta replaces an analysis for [Byetta] LAR," due to the inclusion of studies that have only three months of data, as well as to the data being retrospective.

Regarding the Byetta LAR regulatory filing, the companies said analyses have been "successfully completed" to demonstrate that the drug produced at Amylin's commercial plant is comparable to the product manufactured at Alkermes' facility and used in clinical trials. Last November, concerns were raised that the drug could face regulatory delays over questions about comparability.

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