Lilly Submits NDA for Tirzepatide Injection for Chronic Weight Management in Adults in China

According to the official website of the Center for Drug Evaluation under the National Medical Products Administration, the registration application for tirzepatide injection by Eli Lilly and Company, aimed at long-term weight management in adult patients with obesity or overweight accompanied by at least one weight-related comorbidity, based on a low-calorie diet and increased exercise, has been officially accepted.

Tirzepatide is the first and currently only glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist. It was approved by the U.S. Food and Drug Administration (FDA) in May 2022 for improving glycemic control in adults with type 2 diabetes (in conjunction with diet and exercise) and has already been approved in the European Union, Japan, and other countries. In September 2022, Eli Lilly submitted a registration application in China for the use of tirzepatide in glycemic control in adult patients with type 2 diabetes, which is currently under review. In October 2022, the FDA granted tirzepatide Fast Track designation for long-term weight management in obese or overweight adults with at least one comorbidity (in combination with a low-calorie diet and increased physical activity), to expedite the approval process for this indication.

Obesity is a chronic metabolic disease characterized by an excessive total body fat content and/or increased local fat content and abnormal distribution. Over 200 comorbidities are associated with obesity, including cardiometabolic disorders, inflammatory conditions, degenerative diseases, mechanical injuries, tumors, and psychological disorders. With industrialization, urbanization, and lifestyle changes, more than half of Chinese adults are obese (16.4%) or overweight (34.3%), with the total number (approximately 532 million) now ranking first in the world, posing a serious threat to the health of the Chinese population.

The registration application for tirzepatide for long-term weight management in adults is based on the results of 26 clinical studies of tirzepatide, including the Chinese obesity or overweight registrational clinical trial SURMOUNT-CN. The co-primary endpoint results showed that at 52 weeks of treatment, the mean percentage change in body weight from baseline in the tirzepatide 10mg and 15mg treatment groups was -14.4% and -19.9%, respectively, superior to the placebo group (-2.4%); the proportion of patients achieving ≥5% weight loss in the tirzepatide groups (10mg, 91.4%; 15mg, 92.7%) was superior to the placebo group (29.4%). Additionally, the proportion of patients achieving ≥15% weight loss in the tirzepatide groups (10mg, 48.6%; 15mg, 72.1%) was also superior to the placebo group (2.9%). The overall safety profile of tirzepatide is similar to known GLP-1 receptor agonists, with the most common adverse reactions being mild to moderate gastrointestinal adverse reactions, primarily occurring during the dose escalation period, decreasing with continued dosing, and tolerable by the vast majority of patients who can adhere to treatment. The results of SURMOUNT-CN will be presented at the European Association for the Study of Diabetes (EASD) Annual Meeting in October this year.

About Tirzepatide

Tirzepatide, a GIP/GLP-1 receptor agonist administered through once-weekly injection, is a single-molecule peptide that binds to and activates the human body's natural incretin receptors, GIP receptor and GLP-1 receptor. Both GIP receptor and GLP-1 receptor are expressed in key areas of the brain responsible for regulating appetite. Tirzepatide reduces food intake, lowers body weight, and decreases fat mass by reducing calorie intake and modulating appetite; additionally, tirzepatide has been shown to regulate lipid utilization. The long-term weight management effects of tirzepatide in obese or overweight adults with weight-related comorbidities are currently in Phase III clinical development.

Previously, tirzepatide was approved by the FDA on May 13, 2022, for improving glycemic control in adults with type 2 diabetes in conjunction with diet and exercise. The potential treatment of tirzepatide is also being studied for obesity or overweight patients with heart failure with preserved ejection fraction (HFpEF), obstructive sleep apnea (OSA), and non-alcoholic steatohepatitis (NASH). Additionally, studies on tirzepatide regarding morbidity and mortality outcomes (MMO) in chronic kidney disease (CKD) and obesity are ongoing.

Editor: Mu Mian

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