Novartis Receives FDA Approval for Label Update On Use of Leqvio (Inclisiran)

Last Updated: Thursday, 13-Jul-2023 14:45:00 EDT

Novartis received FDA approval for a label update that will allow for use of Leqvio ® (inclisiran) in certain patients at high risk of cardiovascular (CV) disease. This broader population allows for earlier Leqvio treatment in patients with elevated low-density lipoprotein cholesterol (LDL-C) and CV risk factors, such as diabetes and hypertension, who are at increased risk of atherosclerotic cardiovascular disease (ASCVD), beyond the previously approved ASCVD and heterozygous familial hypercholesterolemia (HeFH) patient population.

Leqvio is now indicated as an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including HeFH, to reduce LDL-C. Adverse reactions in clinical trials reported by ≥3% of patients treated with Leqvio and more frequently than placebo include injection site reaction, arthralgia, and bronchitis. For your reference, here is a link to the full Prescribing Information.

Novartis is committed to addressing the burden of cardiovascular disease. LDL-C is one of the most readily modifiable risk factors for CV disease.