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Sanofi says diabetes drug on track to be resubmitted to U.S. FDA in Q3
June 8, 2015 / 4:47 PM / 2 years ago

Sanofi says diabetes drug on track to be resubmitted to U.S. FDA in Q3

PARIS, June 8 (Reuters) - Sanofi said on Monday that it was on track to resubmit an application for authorisation of its lixisenatide drug for the treatment of type 2 diabetes to the U.S. Food and Drug Administration (FDA) in the third quarter.

This follows a positive late-stage study of the drug designed to assess its cardiovascular safety in adults with type 2 diabetes and high heart risk.

Sanofi said in March that the Phase IIIb study had shown it did not increase cardiovascular risk.

Lixisenatide won marketing approval in Europe under the name Lyxumia in 2013 after being in-licensed by Sanofi from Zealand Pharma. The same year, Sanofi withdrew its application with the FDA, saying it feared that incomplete data on the patient study might influence doctors’ and patients’ responses. (Reporting by James Regan; Editing by Ingrid Melander)

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