Novartis' First-in-Class Inclisiran Sodium Injection Receives New Indication Application Acceptance in China

Intelligent Finance APP learned on April 7 that the CDE official website showed that Novartis (NVS.US) Inclisiran Sodium Injection's new indication marketing application has been accepted. Based on clinical progress and public information, the Insight database speculates that the indication is for adult patients with moderate or low-risk atherosclerotic cardiovascular disease (ASCVD) who have not received any lipid-lowering treatment and have elevated low-density lipoprotein cholesterol (LDL-C).

Screenshot source: CDE official website

Inclisiran sodium is the world's first and currently the only small interfering RNA drug that lowers LDL-C. It was approved for marketing by the EU in 2020 and by the FDA in 2021 for the treatment of adult hypercholesterolemia and mixed dyslipidemia, demonstrating the therapeutic potential of small nucleic acid drugs in the field of chronic diseases. To date, this drug has been approved in nearly 100 countries, including the United States, the European Union, and China. In the EU, it has received approval for four indications, in the United States for three indications, and in China for four indications.