FDA Approves Expanded Indication for Leqvio

Leqvio can now be used earlier in LDL-C treatment as an adjunct to diet and statin therapy for patients who have not had a cardiovascular event but are at an increased risk of heart

July 10, 2023 — Novartis announced that the US Food and Drug Administration (FDA) has approved a label update for Leqvio (inclisiran) to enable earlier use in patients with elevated LDL-C who have an increased risk of heart disease, as an adjunct to diet and statin therapy¹. This patient population includes those who have comorbidities such as hypertension and diabetes and have not yet had a first cardiovascular event².

"Novartis is committed to addressing the rising burden of cardiovascular disease, a substantial public health burden affecting 30 million Americans," said Victor Bulto, President of Novartis Innovative Medicines US. "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."

Initially approved by the FDA in December 2021, Leqvio is the first and only small interfering RNA (siRNA) therapy to lower LDL-C. The updated indication for primary hyperlipidemia allows for the expanded use of Leqvio as an adjunct to diet and statin therapy beyond the previously approved atherosclerotic cardiovascular disease (ASCVD) and heterozygous familial hypercholesterolemia (HeFH) patient populations¹.

With two doses a year, after two initial doses, Leqvio was proven to provide powerful and consistent LDL-C lowering of up to 52% vs. placebo for patients with heart disease or at increased risk of heart disease, who were unable to reach their LDL-C target despite statin therapy^1,3,4. After administration of Leqvio by a health care provider (HCP), HCPs can be confident that a dose won't be missed for 6 months¹.

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. Effective immediately in the US, this label update reinforces the robust safety and effectiveness data for Leqvio that are being generated by the VictORION clinical trial program. VictORION is one of the largest cardiovascular clinical trial programs with more than 20 trials and is designed for consistent and comprehensive data generation.

For more information: www.novartis.us

References

Leqvio prescribing information. East Hanover, NJ: Novartis Pharmaceuticals Corp; 2023.
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Ray KK, Wright RS, Kallend D, et al. Two phase 3 trials of inclisiran in patients with elevated LDL cholesterol. N Engl J Med. 2020;382(16):1507-1519. doi:10.1056/NEJMoa1912387  
Raal FJ, Kallend D, Ray KK, et al. Inclisiran for heterozygous familial hypercholesterolemia. N Engl J Med. 2020;382(16):1520-1530. doi:10.1056/NEJMoa1913805 
Heart disease facts. Centers for Disease Control and Prevention; 2020. Accessed June 23, 2023. https://www.cdc.gov/heartdisease/facts.htm
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Arnett D, Blumenthal R, Albert M, et al. 2019 ACC/AHA Guideline on the Primary Prevention of Cardiovascular Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Circulation. 2019;140(11):e596-e646. doi: 10.1161/CIR.0000000000000678
Ahmad FB, Anderson RN. The leading causes of death in the US for 2020. JAMA. 2021;325(18):1829-1830. doi:10.1001/jama.2021.5469
Centers for Disease Control and Prevention. Vital Signs: Preventing 1 Million Heart Attacks and Strokes; 2018. Accessed June 23, 2023. https://www.cdc.gov/vitalsigns/million-hearts/index.html