The US FDA has approved two additional doses of Eli Lilly’s Trulicity (dulaglutide) for the treatment of type 2 diabetes.
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 3 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.
Juan Pablo Frias, Medical Director and Principal Investigator at the National Research Institute, said: “This progressive condition can require different treatment approaches over time, and findings from AWARD-11 showed the additional doses of Trulicity can lead to further A1C and weight reductions for people with type 2 diabetes whose current treatment may no longer be meeting their needs.”
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.