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诺和诺德(NVO.US)每周注射糖尿病药物Kyinsu于欧盟获批
Zhi Tong Cai Jing· 2025-09-19 11:53
Core Viewpoint - Novo Nordisk's weekly injectable diabetes drug has received EU approval, providing patients with an additional treatment option [1] Group 1: Drug Approval and Composition - The European Medicines Agency's drug review panel recommended the approval of Kyinsu for treating type 2 diabetes patients [1] - The drug is a combination of insulin and semaglutide, the active ingredient in Novo Nordisk's popular weight loss drug Ozempic, and is also known as IcoSema [1] Group 2: Clinical Efficacy - Clinical trials indicate that the drug helps type 2 diabetes patients better control their weight and lower blood sugar levels, outperforming daily insulin injections [1] - The drug is particularly beneficial for patients who struggle to manage diabetes through daily insulin injections [1] Group 3: Regulatory Challenges - The long-acting insulin component of the drug was previously rejected by the U.S. Food and Drug Administration due to the need for more detailed information regarding the manufacturing process and indications for type 1 diabetes [1]