The National Medical Products Administration has granted approval to Novo Nordisk’s (NYSE: NVO) once-weekly semaglutide injection, marketed as Ozempic. This approval covers the treatment of adults with chronic kidney disease (CKD) and type 2 diabetes (T2DM), specifically targeting the reduction of eGFR decline, end-stage renal disease, and cardiovascular death. Ozempic is now the first and only GLP-1 receptor agonist in China approved for glycemic control, cardiovascular protection, and renal protection.
Clinical Trial Results
The FLOW trial demonstrated that Ozempic, when used in conjunction with standard RAAS blockade, significantly reduced the composite renal endpoint by 24%. It also slowed eGFR loss, improved UACR, and decreased cardiovascular events by 18%. The drug’s prefilled pen can be used across mild-to-severe renal or hepatic impairment without the need for dose adjustment.
Significance of the Approval
This new indication establishes GLP-1 receptor agonists as a fourth pillar in the management of CKD-T2DM, alongside glycemic control, blood pressure management, and lipid control. It is anticipated that this approval will lead to a shift in clinical guidelines, positioning Ozempic as a cornerstone in the treatment of these conditions.-Fineline Info & Tech
