Eli Lilly's Dulaglutide Receives NMPA Approval in China for New Indication in Combination with Insulin for Type 2 Diabetes

On September 15, the official website of the National Medical Products Administration (NMPA) showed that the new indication application for Eli Lilly's dulaglutide injection (brand name: Trulicity) has been approved. Based on the previously announced completion of Phase III clinical trials in China by Eli Lilly, it is speculated that the newly approved indication is for dulaglutide in combination with insulin for the treatment of adult type 2 diabetes.

Dulaglutide is a long-acting human GLP-1 receptor agonist. Dulaglutide exhibits GLP-1 mediated effects, including glucose-dependent insulin secretion, inhibition of glucagon secretion, delayed gastric emptying, and reduced food intake through central appetite suppression. These mechanisms of action can demonstrate blood glucose-lowering effects. Dulaglutide is administered once weekly, offering advantages such as effectively lowering HbA1c, moderately reducing body weight, low risk of hypoglycemia, and low immunogenicity.

In August 2022, Eli Lilly and Company announced that dulaglutide significantly reduced glycated hemoglobin (HbA1c), body weight, and fasting serum glucose in patients with type 2 diabetes during the 28-week AWARD-CHN3 clinical trial (dulaglutide combined with titrated insulin glargine for the treatment of adult type 2 diabetes). The study achieved both its primary and all key secondary endpoints.

Today, Eli Lilly's insulin glargine injection has also been approved for marketing in China, for the treatment of type 2 diabetes.

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