Sanofi withdraws US application for lixisenatide diabetes drug

Drugmaker Sanofi suffered a big setback last week after making an unexpected u-turn on its decision to market its diabetes drug lixisenatide in the USA.
The French pharmaceutical firm announced last week that it had withdrawn its lixisenatide application with the US Food and Drug Administration (FDA) in order to wait for results from an ongoing cardiovascular safety trial.
It now plans to resubmit the application in 2015, following the completion of its 6,000-patient ELIXA study.
Sanofi insisted its decision to pull the application was not related to any safety issues concerning the drug or problems with the application. Instead, it follows discussions with the FDA over concerns that “potential public disclosure” of early interim trial data could compromise the integrity of the ongoing study.
It also noted that a combination of lixisenatide and Lantus (basal insulin) remains on schedule to enter into Phase III clinical trials in the first half of 2014.
Lixisenatide is once-daily GLP-1 inhibitor for the treatment of adults with type 2 diabetes who are unable to achieve adequate blood glucose control with oral diabetes medication and/or basal insulin.
In the UK the injectable drug is currently only available to diabetic patients in Scotland, following its approval by the Scottish Medicines Consortium (SMC) earlier this month.