Posted by Michael Wonder on 03 Sep 2020
FDA approves additional doses of Trulicity (dulaglutide) for the treatment of type 2 diabetes mellitus
3 September 2020 - AWARD-11 showed 3.0 mg and 4.5 mg doses led to additional blood sugar control; as a secondary outcomes, both doses also led to weight loss.
The U.S. FDA today approved two additional doses of Eli Lilly'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 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 mellitus.
