FDA approves Leqvio (inclisiran), first-in-class small interfering RNA therapy for adults with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH) who require additional lowering of LDL-Cholesterol

Last Updated: Thursday, 23-Dec-2021 00:30:00 EST

Novartis announced that the U.S. Food and Drug Administration (FDA) approved Leqvio (inclisiran) as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with clinical atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH) who require additional lowering of LDL-Cholesterol. Inclisiran is the first FDA-approved small interfering RNA (siRNA) therapy to lower low-density lipoprotein cholesterol. Patients on inclisiran, which is given by subcutaneous injection, will take two doses a year following two loading doses, an initial dose and one at three months.  In clinical trials of inclisiran, LDL-cholesterol was reduced by about 50%.

Inclisiran decreases the synthesis of PCSK9 in hepatic cells, leading to upregulation of LDL receptors, and thus increased clearance of LDL. A cardiovascular outcomes trial with inclisiran is in progress.

To read the full press release announcing the FDA decision, click here.