FDA Approves Higher Doses of Trulicity® (Dulaglutide) to Enhance Glycemic Control and Weight Loss in Type 2 Diabetes

September 04, 2020 News /BioValleyBIOON/ --Eli Lilly(Eli Lilly) recently announced that the U.S. Food and Drug Administration (FDA) has approved two additional doses (3.0 mg, 4.5 mg) of Trulicity (Chinese brand name: Du Yida; generic name: dulaglutide), a glucagon-like peptide-1 (GLP-1) receptor agonist (RA) administered once weekly for the treatment of type 2Diabetes. The approval is based on data from the Phase 3 AWARD-11 study. Results showed that in type 2DiabetesIn patients, higher doses (3 mg, 4.5 mg) further improved glycemic control and reduced body weight compared with the approved dose (1.5 mg). The higher doses of Trulicity are currently under review by the European Medicines Agency (EMA).

Juan Pablo Frias, M.D., Medical Director and Principal Investigator at the National Research Institute (NRI), stated: “FDAThe decision to approve additional doses of Trulicity for type 2DiabetesThis represents a positive advancement for patients and their caregivers. Over time, this progressive disease may require different treatment approaches. Results from the AWARD-11 study demonstrate that for type 2 diabetes patients whose current treatment no longer meets their needs,Diabetes“Patients, an additional dose of Trulicity can further lower blood glucose and body weight.”

AWARD-11 was a randomized, double-blind, parallel-group Phase III study that enrolled 1,842 patients with type 2 diabetes to evaluate the safety and efficacy of two higher doses of Trulicity (3.0 mg and 4.5 mg, administered once weekly) compared with the approved 1.5-mg dose (administered once weekly). The primary objective was to demonstrate that, in patients with type 2 diabetes who had inadequate glycemic control on metformin monotherapy, once-weekly higher doses provided superior glycemic efficacy over 36 weeks compared with the approved 1.5-mg dose. Secondary and exploratory endpoints included mean change in body weight, proportion of patients achieving hemoglobin A1c <7%, fasting plasma glucose (FPG), and incidence of hypoglycemia during 36 and 52 weeks of treatment.

This study employed two distinct statistical methods (efficacy assessment and treatment regimen evaluation) to assess the efficacy and safety of high doses (3.0 mg and 4.5 mg) compared with the approved dose of 1.5 mg.Efficacy Assessment Methods: An analysis of subjects who continuously received treatment throughout the trial showed that:Compared with the 1.5 mg dose, both the 3 mg and 4.5 mg doses significantly reduced blood glucose levels (A1C) and body weight.. Specific data are as follows: (1) A1C reduction: -1.9% (4.5 mg), -1.7% (3 mg), -1.5% (1.5 mg). (2) Weight loss: -10.4 lbs (4.5 mg), -8.8 lbs (3 mg), -6.8 lbs (1.5 mg).

In this study, the safety and tolerability profiles of high-dose Trulicity (3 mg and 4.5 mg) were consistent with the known profile of Trulicity 1.5 mg. The most common adverse events at each dose were gastrointestinal in nature.

Eli LillyDr. Leonard Glass, Vice President of Medical Affairs, stated, “Diabetes is a complex disease that may require additional therapies over time to maintain glycemic control. The Trulicity pre-filled pen is simple and easy to use, and the product is the most prescribed GLP-1 receptor agonist in the United States. The approval of higher doses (3.0 mg and 4.5 mg) will enable patients with type 2 diabetes treated with Trulicity to achieve therapeutic benefits from additional reductions in blood glucose and body weight as their disease progresses.”

Trulicity is a glucagon-like peptide-1 (GLP-1) receptor agonist (RA) administered once weekly. It has also been approved, in conjunction with diet and exercise, to improve glycemic control in adult patients with type 2 diabetes. In February 2020, Trulicity was approved by the U.S.FDAApproval of a new indication to reduce the risk of major adverse cardiovascular events (MACE) in adult patients with type 2 diabetes who have cardiovascular (CV) disease or multiple cardiovascular risk factors. Notably, this approval makes Trulicity the first type 2 diabetes medication approved to reduce the risk of MACE in both primary and secondary prevention populations.

In China, Trulicity (Duyida, dulaglutide) was approved in February 2019 and officially launched in June 2019. GLP-1 RAs are a highly anticipated class of diabetes medications. GLP-1 RAs are not insulin; rather, they are a novel class of insulin secretagogues. Their mechanism of action is similar to that of the endogenous hormone GLP-1, promoting the secretion of the patient’s own insulin in response to meal intake. They offer potent glucose-lowering efficacy, a lower risk of hypoglycemia, and additionally possessWeight LossEfficacy and advantages in conferring cardiovascular benefits.

Since its U.S. market launch in 2014, Trulicity has become the most prescribed GLP-1 receptor agonist (GLP-1RA). In addition to its proven glucose-lowering efficacy and user-friendly delivery device, Trulicity is now also indicated to help reduce the risk of cardiovascular events in patients with type 2 diabetes. According to forecasts by the pharmaceutical market research firm EvaluatePharma, Trulicity’s sales will reach $7.13 billion in 2024, making it the best-selling antidiabetic medication worldwide. (Bioon.com)

Original Source:FDA approves additional doses of Trulicity® (dulaglutide) for the treatment of type 2 diabetes