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FDA approves Trulicity for Type II diabetes

September 19, 2014 2:44 AM UTC

FDA approved a BLA for Trulicity dulaglutide from Eli Lilly and Co. (NYSE:LLY) to improve glycemic control in Type II diabetes patients, in conjunction with diet and exercise.

The once-weekly subcutaneous GLP-1 receptor agonist was approved based on data from 3,342 Type II patients showing superiority of Trulicity to placebo and non-inferiority compared to metformin; Januvia sitagliptin from Merck & Co. Inc. (NYSE:MRK); Byetta exenatide from AstraZeneca plc (LSE:AZN; NYSE:AZN) and Lantus insulin glargine from Sanofi (Euronext:SAN; NYSE:SNY). ...