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Sanofi withdraws lixisenatide NDA

September 13, 2013 12:25 AM UTC

Sanofi (Euronext:SAN; NYSE:SNY) withdrew an NDA for lixisenatide, which was under FDA review to treat Type II diabetes with an undisclosed PDUFA date. Sanofi said based on discussions with FDA that it is concerned about the agency's proposed process to review early interim data from the ongoing Phase III ELIXA cardiovascular outcomes trial, which was included in the NDA. The pharma said it is concerned about the potential public disclosure of the interim data, which it said could "compromise the integrity" of ELIXA. Final data from ELIXA are expected by the end of 2014, with an NDA resubmission expected in 2015. ...