By Fineline Cube 
Swiss pharmaceutical giant Novartis (NYSE: NVS) announced on August 12, 2025, that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Leqvio (inclisiran). The drug can now be used as a standalone therapy, in addition to diet and exercise, to lower low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia.
Label Updates
The updated FDA label removes the previous restriction that Leqvio must be used in combination with or on top of statin therapy. Additionally, the term “primary hyperlipidemia” has been changed to the more specific “hypercholesterolemia,” better reflecting Leqvio’s role in reducing LDL-C.
Mechanism of Action
Inclisiran is the world’s first and currently the only small interfering ribonucleic acid (siRNA) drug designed to lower LDL-C. It works by blocking the synthesis of PCSK9, a protein that contributes to increased LDL-C levels. By targeting the source of LDL-C elevation, inclisiran provides long-term, stable reduction of LDL-C.-Fineline Info & Tech