FDA Approves Additional Doses of Trulicity (dulaglutide) for the Treatment of Type 2 Diabetes

The U.S. Food and Drug Administration (FDA) today 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, M.D., 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.

About the AWARD-11 Study

The phase 3, randomized, double-blind, parallel arm study included 1,842 participants with type 2 diabetes and evaluated the efficacy and safety of two investigational doses of dulaglutide (3.0 mg and 4.5 mg) compared to Trulicity 1.5 mg. The primary objective of the study was to demonstrate that a once-weekly investigational dulaglutide dose (3.0 mg and/or 4.5 mg) was superior to the approved Trulicity 1.5 mg dose, as measured by A1C reduction from baseline, at 36 weeks in people with inadequately controlled type 2 diabetes on concomitant metformin therapy. The primary and secondary objectives could be met if one or both doses achieved statistical significance for the endpoints. Secondary and exploratory outcomes included change from baseline in mean body weight and fasting serum glucose (FSG), percentage of patients reaching an A1C goal of less than seven percent and occurrence of hypoglycemic episodes and pharmacokinetics at steady-state through 36 and 52 weeks. All participants started the study at a dose of Trulicity 0.75 mg once-weekly and then increased the dose in a step-wise approach at four week intervals to their final randomized maintenance dose of once-weekly 1.5 mg, 3.0 mg (via a 1.5 mg step) or 4.5 mg (via steps at 1.5 mg and 3.0 mg).

About Diabetes

Approximately 34 million Americans1 (just over 1 in 10) and an estimated 463 million adults worldwide2 have diabetes. Type 2 diabetes is the most common type internationally, accounting for an estimated 90 to 95 percent of all diabetes cases in the United States alone1. Diabetes is a chronic disease that occurs when the body does not properly produce or use the hormone insulin.

About Lilly Diabetes

Lilly has been a global leader in diabetes care since 1923, when we introduced the world's first commercial insulin. Today we are building upon this heritage by working to meet the diverse needs of people with diabetes and those who care for them. Through research, collaboration and quality manufacturing we strive to make life better for people affected by diabetes and related conditions. We work to deliver breakthrough outcomes through innovative solutions—from medicines and technologies to support programs and more. For the latest updates, visit http://www.lillydiabetes.com/ or follow us on Twitter: @LillyDiabetes and Facebook: LillyDiabetesUS.

About Eli Lilly and Company

Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism. To learn more about Lilly, please visit us at lilly.com and lilly.com/newsroom. P-LLY

Trulicity® is a registered trademark owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates.

This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about dulaglutide 3.0 mg and/or 4.5 mg as a potential treatment for people with type 2 diabetes and reflects Lilly's current belief. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of development and commercialization. Among other things, there can be no guarantee that future study results will be consistent with the results to date or that dulaglutide 3 mg and/or 4.5 mg will receive additional regulatory approvals. For further discussion of these and other risks and uncertainties, see Lilly's most recent Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release.

1 Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2020. Atlanta, GA: Centers for Disease Control and Prevention, U.S. Dept. of Health and Human Services; 2020.

2 International Diabetes Federation. IDF Diabetes Atlas, 9th edn. Brussels, Belgium: International Diabetes Federation, 2019. Available at: http://diabetesatlas.org. 

i The efficacy estimand was used to evaluate results in participants who stayed on treatment and did not start another diabetes medicine throughout the trial. The treatment-regimen estimand, conducted based on regulatory guidance, includes data from all participants through the end of the trial, which may include confounding effects of rescue medication or discontinuation from the study drug or the trial. In the treatment-regimen estimand, which was conducted based on regulatory guidance, each dose led to clinically meaningful A1C and body weight reductions but only the 4.5 mg dose showed superiority compared to Trulicity 1.5 mg.              

SOURCE Eli Lilly and Company