PARIS, March 19 (Reuters) - Sanofi’s lixisenatide drug for the treatment of type 2 diabetes does not increase cardiovascular risk among high risk patients, the French drugmaker said on Thursday.
Sanofi was reporting the results of a study it has been waiting to complete before seeking U.S. approval.
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, Sanofi said.
The study compared lixisenatide to placebo, and showed that the treatment was “non-inferior, although not superior, to placebo for cardiovascular safety,” it said.
Lixisenatide won marketing approval in Europe under the name Lyxumia in 2013 after being in-licensed by Sanofi from Zealand Pharma.
However, the same year, Sanofi withdrew its application with the U.S. Food and Drug Administration, saying it feared that incomplete data on the patient study might influence doctors’ and patients’ responses and distort the outcome of the double-blind trial.
At the time Sanofi said it would re-submit a U.S. new drug application with the FDA once the study was complete. On Thursday it said the results supported its plans to do that in the third quarter of this year.
FDA guidance on anti-type 2 diabetes treatments requests any company seeking approval for one to reveal what data it has on the associated cardiovascular risk.
Reporting by Andrew Callus, Editing by Dominique Vidalon; Editing by Sunil Nair