FDA approves additional doses of Trulicity® (dulaglutide) for the treatment of type 2 diabetes
September 9, 2020

AWARD-11 showed 3.0 mg and 4.5 mg doses led to additional blood sugar control; as a secondary endpoint, both doses also led to weight loss

The U.S. Food and Drug Administration (FDA) approved two additional doses of Eli Lilly and Company's (NYSE: LLY) 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.

"The FDA's decision to approve the additional doses of Trulicity is a positive step forward for people living with type 2 diabetes and their care teams," said Juan Pablo Frias, MD, Medical Director and Principal Investigator, National Research Institute. "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."

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[i]. 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)

"People find the Trulicity pen simple and easy-to-use," said Leonard Glass, M.D., F.A.C.E, vice president of Medical Affairs, Lilly. "Now, with the 3.0 and 4.5 doses available, people with type 2 diabetes who use Trulicity can benefit from additional A1C and weight loss as their condition progresses."

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.