▎WuXi AppTec Content Team Report
Today (November 12), the website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced that Eli Lilly and Company...(Eli Lilly and Company) Blockbuster DrugGIP/GLP-1 Receptor Dual AgonistTirzepatide InjectionThe marketing application for the new indication has been accepted, but the specific indication has not been disclosed. According to the query on the CDE official website, this isTirzepatide's Fourth Marketing Application Submission in China.
Screenshot Source: CDE official website
Tirzepatide（tirzepatide）YesA glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist, administered once weekly.The product received FDA approval in May 2022 and November 2023, respectively, for use in diabetes, obesity, and overweight patients. In China,TirzepatideTodayYear MayApprovedThe first indication is for blood sugar control in adult patients with type 2 diabetes. In July this year, the product was again approved by the NMPA for improving obesity in adults or overweight patients with at least one weight-related comorbidity.Long-term Weight Management。
At present, Eli Lilly and Company continues to explore.TirzepatideApplications in various indications. Early August,Eli LillyAnnouncementApplications have been submitted to regulatory authorities in Europe and the United States seeking approval.TirzepatideImprove snoring conditions in obese patients with moderate to severe obstructive sleep apnea (OSA).Eli LillyPointed out that this indication is likely to receive FDA approval by the end of this year at the earliest.SURMOUNT-OSA Clinical TrialThe test results showed,Compared with placebo,TirzepatideAverage reduction in patients' Apnea-Hypopnea Index (AHI) by up to 62.8%, equating to approximately 30 fewer events of restricted or obstructed airflow per hour of sleep.In China,Tirzepatide forInternational multicenter (including China) clinical studies on obstructive sleep apnea and obesity indications have also been completed.On November 21 this year, Eli Lilly and Company also announced that it had begun submitting tirzepatide for treatment to global regulatory authorities.Heart Failure with Preserved Ejection Fraction (HFpEF) in Patients with ObesityIndication Application. The SUMMIT Phase 3 clinical study has achieved two primary endpoints. Compared with placebo,Tirzepatide Reduces Risk of Heart Failure Events (Assessed by Composite Endpoint) by 38% and Lowers Risk of Heart Failure Hospitalization by 56%。It is worth mentioning that,SUMMIT TrialThe portion in China has also been completed, with 55 subjects enrolled in China.。
We hope this innovative therapy will soon reach more patients, bringing them new treatment options.
References:
[1] Website of the Center for Drug Evaluation (CDE) under the China National Medical Products Administration (NMPA). Retrieved Nov 22, 2024, from https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c
[2]Detailed Data of Tirzepatide SUMMIT Study Released..Retrieved Nov 21，2024, From https://mp.weixin.qq.com/s/y8ZNy9zwo8xa2i8VOnKM9wThis article was compiled and edited by the content team of WuXi AppTec based on publicly available information. Individuals are welcome to share it on their social media feeds. For authorization to repost or other collaboration inquiries, please contact wuxi_media@wuxiapptec.com.
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