Eli Lilly Submits New Indication Application for Dulaglutide in China to Expand Use with Insulin for Adults with Type 2 Diabetes

Intelligent Finance APP learned on January 11 that the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration disclosed that Eli Lilly and Company (LLY.US) had submitted a new indication marketing application for dulaglutide injection. Public information shows that dulaglutide is aLong-acting GLP-1 receptor agonist, administered once weekly,Previously approved in China for adult Type 2 diabetes。In July 2022, Eli Lilly and Company announced that dulaglutide had met the primary endpoint in a Phase 3 clinical trial conducted in China, which would support the application for a new indication in China.Combination Insulin Therapy for Adult Type 2 Diabetes。

Screenshot source: CDE official website

Human Glucagon-like Peptide-1 (GLP-1) is a peptide hormone secreted by intestinal cells. It stimulates insulin secretion and inhibits glucagon secretion by binding to the GLP-1 receptor, thereby promoting glucose metabolism. At the same time, it can also slow gastric emptying and suppress appetite. Natural GLP-1 is secreted after meals when stimulated by glucose. In patients with type 2 diabetes, the secretion level of GLP-1 is significantly reduced, which is one of the important reasons for poor blood glucose control.

Dulaglutide is a long-acting GLP-1 receptor agonist administered once weekly, which effectively reduces glycated hemoglobin (HbA1c), moderately promotes weight loss, and offers the advantages of low hypoglycemia risk and low immunogenicity.Dulaglutide was first approved by the U.S. FDA in 2014 and has since been approved in many regions around the world for glycemic control in adults with type 2 diabetes, including as monotherapy and combination therapy. In February 2020, the drug received another FDA approval to reduce the risk of major adverse cardiovascular events (MACE) in adult patients with type 2 diabetes who have cardiovascular disease or multiple cardiovascular risk factors.

In China, dulaglutide was approved for marketing in 2019.For blood glucose control in adult patients with type 2 diabetes, including monotherapy and patients whose blood glucose is still poorly controlled despite treatment with metformin and/or sulfonylureas.

In July 2022, Eli Lilly and Company announced that the Phase 3 AWARD-CHN3 study of dulaglutide in combination with insulin therapy met the primary endpoint and all key secondary endpoints. This is aConducted in ChinaA multicenter, randomized, double-blind, parallel-group, placebo-controlled Phase 3 clinical trial, targetingChinese adult patients with type 2 diabetes whose blood glucose remains poorly controlled despite receiving a stable dose of insulin glargine (with metformin and/or acarbose).To compare the efficacy and safety of dulaglutide 1.5 mg or placebo treatment on the basis of titrated insulin glargine therapy. The study enrolled 291 adult patients with type 2 diabetes and was completed at 27 research centers in China.

The results of this study showed that, in the 28-week AWARD-CHN3 study,Dulaglutide Combined with Titrated Insulin Glargine Significantly Reduces HbA1c, Body Weight, and Fasting Serum Glucose in Adults with Type 2 Diabetes。

It is reported that type 2 diabetes is a chronic metabolic disease affecting more than 200 million patients worldwide. The main characteristic of patients is insulin resistance, which prevents insulin from functioning fully. For these patients, the sole use of insulin cannot effectively improve their condition, so they need other types of hypoglycemic drugs to control blood sugar levels.