Novo Nordisk Submits New Indication Application for Semaglutide Injection in China Targeting Cardiovascular Risk Reduction in Overweight and Obese Adults with Established Cardiovascular Disease
Novo Nordisk
Insulin Developer and Manufacturer
▎WuXi AppTec Content Team Report
Today (August 26), the latest announcement on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration revealed that the new indication application for semaglutide injection submitted by Novo Nordisk has been accepted, with no specific indication information disclosed so far. The semaglutide injection, developed by Novo Nordisk, has been successively approved in China for use in...TreatmentType 2 DiabetesAndLong-term Weight ManagementGlobally, semaglutide is undergoing clinical development for more indications. Based on publicly available information, it is speculated that the indication for this marketing application may be...For reducing the risk of cardiovascular death, heart attacks, and strokes in adults with cardiovascular disease and obesity or overweight.. This indication was approved by the US FDA in March this year.
Screenshot source: CDE official website
Semaglutide is a long-acting GLP-1 analog that shares 94% homology with the amino acid sequence of natural GLP-1 and acts as a GLP-1 receptor agonist. Semaglutide injections (0.25, 0.5, and 1.0 mg) were approved in China in April 2021 for treatment.Type 2 Diabetes(trade name: NovoTai, Ozempic); In June 2024, the 2.4mg injection of semaglutide (trade name: NovoWin, Wegovy) was approved in China forLong-term Weight Management。
According to the official website of the China Drug Clinical Trial and Information Disclosure Platform, Novo Nordisk has also conducted several Phase 3 clinical trials of semaglutide injection, including:An international multicenter (including China) phase 3 clinical study(FLOW Study), Evaluate the effect of Semaglutide onProgression of Renal Damage in Patients with Type 2 Diabetes and Chronic Kidney DiseaseFunction;An international multicenter (including China) Phase 3 clinical study to evaluate semaglutide forFunctional Capacity in Patients with Type 2 Diabetes and Peripheral Artery DiseaseThe impact;An international multicenter (including China) Phase 3 clinical study evaluating semaglutide forNon-cirrhotic Nonalcoholic SteatohepatitisImpact on subjects.
Internationally, new progress continues to be made with the semaglutide injection:
In March this year, the U.S. FDAApprovalWegovy forReduce the risk of cardiovascular death, heart attacks, and strokes in adults with cardiovascular disease and obesity or overweight.. In clinical studies,Semaglutide significantly reduced the risk of major adverse cardiovascular events (including cardiovascular death, heart attack, and stroke). The proportion of such events in subjects receiving semaglutide was 6.5%, compared to 8% in the placebo group.
In May this year, Novo Nordisk announced Ozempic at the European Renal Association (ERA) conference.FLOW Phase 3 Clinical TrialThe latest results. Analysis shows that Ozempic reached the primary endpoint and all secondary endpoints of the trial. Compared with the placebo, the productCan reduce the risk of major cardiovascular events by 18% and the risk of death from any cause by 20% in patients with chronic kidney disease (CKD) and type 2 diabetes.According to the previous press release,Novo Nordisk Plans to Submit New Indication Application for Ozempic in the U.S. and EU in 2024.
In August this year, the prestigious medical journal The Lancet released a significantResearch Results. In a study involving more than 4,000Obese patients with a history of heart failure and atherosclerotic cardiovascular diseaseThe pre-specified analysis shows that Wegovy can improve the risk of major adverse cardiovascular events (MACE), cardiovascular death, and all-cause death in patients, regardless of their heart failure subtype. These findings support the safe application of Wegovy.Patients with various types of heart failure。
[1] Official website of the Center for Drug Evaluation, National Medical Products Administration of China. Retrieved Aug 26, 2024, from https://www.cde.org.cn/main/xxgk/listpage/da6efd086c099b7fc949121166f0130c
[2]Official Website of China Drug Clinical Trial and Information Disclosure Platform. From http://www.chinadrugtrials.org.cn/index.html
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