FDA Approves Inclisiran as Monotherapy for LDL Cholesterol Reduction

The U.S. Food and Drug Administration (FDA) has approved inclisiran as a standalone treatment for lowering low-density lipoprotein (LDL) cholesterol, removing the previous requirement to combine it with statins. Novartis announced that the updated labeling now permits the use of inclisiran—an RNA-based therapy—alongside diet and exercise, without the need for additional lipid-lowering medications. This change expands the drug's application, emphasizing its effectiveness in reducing LDL cholesterol levels independently. Inclisiran is administered via subcutaneous injections twice a year, following an initial dose and a subsequent dose at three months. The revised label also updates terminology from "primary hyperlipidemia" to "hypercholesterolemia" to better highlight LDL cholesterol reduction. Victor Bultó, President of Novartis U.S., stated that this label update underscores inclisiran's proven ability to lower LDL-C, a key factor in heart disease risk. The new indication aims to enable earlier intervention and help more patients achieve their LDL cholesterol targets effectively.