Sanofi's (SNY -0.5%) Lyxumia (lixisenatide) met its primary endpoint in an eight-week pharmacodynamic study of a significantly more pronounced lowering of post-prandial glucose after a test meal compared to liraglutide when both were added to optimally-titrated Lantus (insulin glargine). The lowering of post-prandial glucose was measured as the change from baseline in incremental area under the glucose curve for 4 hours after a standardized solid breakfast at week eight.
Lyxumia is currently approved for sale in over 40 countries (ex. U.S.) for the treatment of type 2 diabetes. The company expects to resubmit its NDA in the U.S. in 2015. It withdrew the original NDA in 2013 after discussions with the FDA over interim data in an ongoing cardiovascular outcomes study. The company felt that the public disclosure of the data could potentially compromise the integrity of the study.