Novartis Announces FDA Approval of Leqvio (inclisiran), the First and Only Twice-Yearly siRNA Therapy for Lowering LDL Cholesterol

Source: Instant Pharma News

On December 23, Novartis announced that the U.S. FDA approved Leqvio (inclisiran), which is currently the first and only small interfering RNA (siRNA) therapy for lowering low-density lipoprotein cholesterol (also known as "bad cholesterol" or LDL-C). After the initial injection and the injection treatment at the third month, patients only need to receive treatment twice a year.

Cardiovascular (CV) disease is the leading cause of death globally, claiming more lives than all cancers combined and accounting for one in three deaths worldwide. However, 80% of all CV events can be prevented. Patients with atherosclerotic cardiovascular disease (ASCVD) are most likely to experience a heart attack or stroke due to high cholesterol. The FDA's approval announcement for Leqvio notes that ASCVD affects 18.3 million adults (8%) in the United States. ASCVD is an umbrella term that includes acute coronary syndrome (sudden reduction of blood flow to the heart), peripheral artery disease, heart attacks, and strokes.

Leqvio's approval by the U.S. FDA was based on the results of the Phase 3 clinical trials ORION-9, ORION-10, and ORION-11, which enrolled 3,457 participants with atherosclerotic cardiovascular disease or heterozygous familial hypercholesterolemia (HeFH) who had elevated LDL-C levels despite being on the maximum tolerated dose of statin therapy. At month 17 of the trials, Leqvio effectively and sustainably reduced LDL-C by up to 52% compared to placebo and was reported to be well-tolerated. These clinical results were also published in The New England Journal of Medicine.

Leqvio is an injectable prescription medicine used as an adjunct to diet and maximum tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease or heterozygous familial hypercholesterolemia who require additional lowering of LDL-C. The impact of Leqvio on cardiovascular morbidity and mortality is currently under clinical investigation.

As a "first-in-class" siRNA therapy, Leqvio can bind to the mRNA encoding PCSK9 protein and reduce its level through RNA interference, preventing the liver from producing PCSK9 protein. The function of PCSK9 protein is to inhibit the recycling and reuse of low-density lipoprotein (LDL) receptors. Therefore, reducing the level of PCSK9 protein allows more LDL receptors to return to the surface of hepatocytes, bind with more LDL, and remove them from the blood. Leqvio is a subcutaneous injection administered by healthcare providers, which may benefit patients who struggle to adhere to self-administered medications or drugs requiring more frequent dosing. Leqvio was initially developed by Alnylam Pharmaceuticals, and later Novartis acquired the global rights for the development, manufacturing, and commercialization of Leqvio.

Note: The original text has been abridged.

Reference Source:

[1] FDA approves Novartis Leqvio^® (inclisiran), first-in-class siRNA to lower cholesterol and keep it low with two doses a year. Retrieved 2021-12-23, from https://www.prnewswire.com/news-releases/fda-approves-novartis-leqvio-inclisiran-first-in-class-sirna-to-lower-cholesterol-and-keep-it-low-with-two-doses-a-year-301450125.html

[2] FDA approves add-on therapy to lower cholesterol among certain high-risk adults

. Retrieved 2021-12-23, from https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-add-therapy-lower-cholesterol-among-certain-high-risk-adults

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