FDA approves additional doses of Trulicity for the treatment of type 2 diabetes.- Eli Lilly

The FDA has approved two additional doses of Eli Lilly and Company's Trulicity (dulaglutide). The approval expands the label of once-weekly Trulicity to include 3.0 mg and 4.5 mg doses based on data from AWARD-11. The phase III trial showed the additional doses led to further benefits in A1C and body weight reduction when compared to Trulicity 1.5 mg in people with type 2 diabetes. The AWARD-11 trial evaluated the safety and efficacy of additional doses of Trulicity (3.0 mg and 4.5 mg) compared to Trulicity 1.5 mg, using two different statistical approaches. The efficacy estimand, which analyzes participants who remained on treatment throughout the trial, showed both doses led to significant reductions in A1C and weight:4.5 mg (A1C: -1.9 percent, weight: -10.4- pounds).3.0 mg (A1C: -1.7 percent; weight: -8.8- pounds).1.5 mg (A1C: -1.5 percent; weight: -6.8 pounds. The additional doses of Trulicity will be available in United States pharmacies in late September. Results from AWARD-11 are also under review by the European Medicines Agency's Committee for Medicinal Products for Human Use, with an opinion on whether to recommend approval by the European Commission expected this year.