Lyxumia's delayed entrance into US anti-diabetes drug market could prove successful in the future, says GlobalData's analyst
French drug major Sanofi’s (Euronext: SAN) decision to withdraw Lyxumia’s (lixisenatide). New Drug Application in the USA (The Pharma Letter September 12) might have come as a surprise for some industry observers; but this move might prove successful in the near future, says an analyst with research and consulting firm GlobalData.
In a statement, the pharmaceutical company cited its fear that the Food and Drug Administration’s review of the Evaluation of Lixisenatide in Acute Coronary Syndrome (ELIXA) study would compromise the integrity of this large ongoing cardiovascular outcomes trial.
The ELIXA study began in 2010 and aims to evaluate the cardiovascular risk profile of Lyxumia in patients with type 2 diabetes who have recently had an acute cardiac event and have high cardiovascular risk.
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