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# Novartis Leqvio Gets Expanded Label
- URL: https://www.fdaweb.com/novartis-leqvio-gets-expanded-label/
- Published: 2023-07-10T12:00:00.000Z
- Updated: 2026-09-14T18:42:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154836

FDA has approved a labeling update for Novartis’ Leqvio (inclisiran) to allow earlier use in patients with elevated LDL-C who have an increased risk of heart disease, as an adjunct to diet and statin therapy. “High LDL-C is one of the most readily modifiable risk factors for heart disease and this label update for Leqvio will help us reach a greater number of patients who struggle with lowering their LDL-C,” the company says. Other updates to the label include the removal of the Limitations of Use statement and the safety section was streamlined to remove four adverse events since the frequency of these events were the same as the placebo arm, it says.

Leqvio was originally approved 12/2021 as a treatment to be used with diet and maximally tolerated statin therapy for adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease who require additional lowering of low-density lipoprotein cholesterol. An agency [statement](https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-add-therapy-lower-cholesterol-among-certain-high-risk-adults?ref=fdaweb.com) said Leqvio was approved at a 284 mg dose administered as an initial under-the-skin injection, a second dose at three months, and continued treatment once every six months after that.