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Sanofi says to pull U.S. diabetes drug application
Sep 12, 13 FDA warningsFrench drugmaker Sanofi said on Thursday it would withdraw its U.S. application for diabetes treatment lixisenatide in order to wait for results from an ongoing cardiovascular patient test.
Sanofi said it would resubmit its application in 2015, after the completion of the cardiovascular test, and said the decision was “not related to safety issues or deficiencies in the new drug application.”
Lixisenatide, which was approved for sale in Europe under the brand name Lyxumia, is one of the new products Sanofi is betting on to restore growth after losing several blockbusters to generic competition.
Sanofi expects to have the full results of its evaluation of lixisenatide in acute coronary syndrome, which is focused on patients with high cardiovascular risk, in approximately 15 months.
(Reporting by Lionel Laurent; editing by Blaise Robinson)
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