FDA Approves Novartis’ Cholesterol-Lowering Drug Leqvio

The FDA has greenlit Novartis’ new drug application (NDA) for its cholesterol-lowering drug Leqvio (inclisiran) after rejecting the NDA a year ago over manufacturing concerns.

Novartis received a Complete Response Letter from the agency in December 2020 that cited problems at a third-party manufacturing facility in Europe and said they must be resolved before it could grant approval.

Leqvio is a small interfering RNA (siRNA) therapy for reducing low-density lipoprotein cholesterol (LDL-C). It works by improving the liver’s ability to prevent the production of a protein that plays a role in keeping circulating cholesterol levels high. The FDA-approved indication is as an adjunct to diet and statin therapy for adult patients with atherosclerotic cardiovascular disease (ASCVD) or those with heterozygous familial hypercholesterolemia (HeFH) who require additional lowering of LDL-C.