The Food and Drug Administration (FDA) has approved 2 additional dosage strengths of Trulicity® (dulaglutide; Lilly), 3mg and 4.5mg, for the treatment of type 2 diabetes. Trulicity is currently available in 0.75mg and 1.5mg doses.
The approval was based on data from the randomized, double-blind, parallel-arm phase 3 AWARD-11 trial that evaluated the efficacy and safety of dulaglutide 3mg and 4.5mg compared with dulaglutide 1.5mg, all administered once weekly, in 1842 adult patients with type 2 diabetes who were inadequately controlled on metformin. Results showed that treatment with dulaglutide 3mg and 4.5mg led to significant reductions in HbA1c and weight compared with dulaglutide 1.5mg.
With regard to safety, the 3mg and 4.5mg doses of dulaglutide were found to be consistent with the known profile of dulaglutide 1.5mg. The most common adverse reactions reported were nausea, vomiting, diarrhea, and dyspepsia.
“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.”
Trulicity 3mg/0.5mL and 4.5mg/0.5mL single-dose pens are expected to be available in late September 2020.
Trulicity, a glucagon-like peptide-1 receptor agonist, is currently approved as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes. It is also indicated to reduce the risk of major cardiovascular (CV) events (eg, CV death, nonfatal MI or nonfatal stroke) in adults with type 2 diabetes and established CV disease or multiple CV risk factors.
For more information visit trulicity.com.
- FDA approves additional doses of Trulicity® (dulaglutide) for the treatment of type 2 diabetes. https://www.prnewswire.com/news-releases/fda-approves-additional-doses-of-trulicity-dulaglutide-for-the-treatment-of-type-2-diabetes-301124206.html. Accessed September 4, 2020.
- Trulicity [package insert]. Indianapolis, IN: Eli Lilly and Company; 2020.