Sanofi and Zealand's Lyxumia not superior to placebo in cardiovascular safety Phase IIIb trial

19 March 2015

French drug major Sanofi (Euronext: SAN) has announced top-line results from its Phase IIIb ELIXA study, comparing Lyxumia (lixisenatide) to placebo in a high-risk population of adults with type 2 diabetes.

Lixisenatide is a once-daily prandial GLP-1 receptor agonist, invented by Zealand (Nasdaq Copenhagen: ZEAL) and developed and marketed worldwide ex-USA by Sanofi.

This was a cardiovascular outcomes study evaluating cardiovascular safety. The study showed that lixisenatide was non-inferior, although not superior, to placebo for cardiovascular safety. These results will be included in the New Drug Application to the US Food and Drug Administration for lixisenatide, which will be resubmitted to the FDA in the third quarter of 2015. The drug is currently not approved in the USA.

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