Sanofi re-submits NDA to FDA for Lyxumia (lixisenatide) for Type 2 Diabetes
In Sanofi’s Q2 2015 earnings release it was confirmed that in late July 2015, a New Drug Application (NDA) for Lyxumia (lixisenatide) was submitted to the FDA for regulatory approval of the product for treatment of Type 2 diabetes.
Comment: Sanofi withdrew its NDA in September 2013 to be re-submitted on completion of the ELIXA cardiovascular outcomes trial which has in June 2015 reported a neutral effect on heart failure and other CV events. The findings showed no increased risk in heart failure, pancreatitis, pancreatic cancer or severe hypoglycaemia.
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