Sanofi Pulls U.S. File for Lixisenatide Diabetes Drug
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Sanofi withdrew the application for U.S. approval of an experimental drug called lixisenatide, delaying the company’s effort to bolster sales of diabetes medicines in the world’s biggest pharmaceutical market.
Giving regulators access to data from an existing trial, known as Elixa, to study the treatment’s cardiovascular effects could affect the integrity of the test, the Paris-based company said in a statement today. The drugmaker will resubmit the application in 2015, after completion of the study, Sanofi said. The withdrawal isn’t related to safety issues or deficiencies in the application, Sanofi said.