PARIS: Drugmaker Sanofi said its lixisenatide drug for the treatment of type 2 diabetes did not increase cardiovascular risk among high risk patients in a study it conducted.
The Phase IIIb cardiovascular outcomes study involved more than 6,000 adult patients with type 2 diabetes who were defined as high risk because they had recently experienced a spontaneous acute coronary syndrome event, the French group said.
The study compared lixisenatide to placebo and showed that the treatment was "non-inferior, although not superior, to placebo for cardiovascular safety."
Lixisenatide won marketing approval in Europe under the name Lyxumia in 2013 after being in-licensed by Sanofi from Zealand Pharma. US regulator, the FDA, has yet to approve it. Sanofi said the results support its plans to resubmit a US new drug application in the third quarter of this year.
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