FDA Update: Inclisiran Approved as Add-On Therapy to Reduce LDL-C in High-Risk Adults

The U.S. Food and Drug Administration (FDA) recently approved inclisiran injection (Leqvio) to be used with diet and statin therapy in adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of low-density lipoprotein cholesterol (LDL-C). The treatment is approved as a 284 mg initial injection, followed by a second dose after three months and continued treatment once every six months.

The effectiveness of inclisiran was studied in three randomized, double-blind, placebo-controlled trials (ORION-10, ORION-11 and ORION-9) that enrolled 3,457 adults with HeFH or clinical ASCVD who were taking maximally tolerated statin therapy but required additional LDL-C lowering based on their risk for cardiovascular events. LDL-C levels decreased significantly among participants taking inclisiran in all three trials. The effect of inclisiran on cardiovascular morbidity and mortality has not been determined.

Read the full FDA announcement.

Clinical Topics: Cardiovascular Care Team, Dyslipidemia, Lipid Metabolism, Nonstatins, Novel Agents, Primary Hyperlipidemia, Statins

Keywords: ACC Advocacy, Hyperlipoproteinemia Type II, United States Food and Drug Administration, Cardiovascular Diseases, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Cholesterol, LDL


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