Swiss pharmaceutical giant Novartis (NYSE: NVS) has received approval from the National Medical Products Administration (NMPA) for its cholesterol-lowering drug Leqvio (inclisiran). The drug is approved for use as an adjunct treatment with diet for adult patients with primary hypercholesterolemia, including heterozygous familial and non-familial cases, or mixed type dyslipidemia. This approval encompasses use in combination with statins or other lipid-lowering therapies for patients who cannot achieve LDL-C targets even after receiving the maximum tolerable dose of statins, and for those who are intolerant or contraindicated to statins.
Inclisiran: A Revolutionary siRNA Drug for LDL-C Reduction
Inclisiran is the world’s first and only small interfering RNA (siRNA) drug designed to lower low-density lipoprotein cholesterol (LDL-C). It works by blocking the synthesis of PCSK9, a protein that increases LDL-C levels, thereby reducing LDL-C levels stably over the long term. The drug offers a convenient dosing schedule, requiring only two injections per year, with the first booster injection administered three months after the initial injection. Clinical studies have demonstrated that for patients who cannot meet LDL-C standards even with the maximum tolerable dose of statins, inclisiran can reduce LDL-C levels by up to 54%.
Sustained Efficacy and Safety of Inclisiran
Five years of clinical research data have shown that inclisiran maintains its efficacy and exhibits good safety and tolerance profiles. This approval in China further expands the global reach of Novartis’s innovative treatment for hypercholesterolemia, offering a new option for patients in need of effective cholesterol management.-Fineline Info & Tech
