FDA approves expanded use of inclisiran for primary hyperlipidemia

The US Food and Drug Administration has approved expanded use of inclisiran (Leqvio) for primary hyperlipidemia besides its existing indications of atherosclerotic cardiovascular and heterozygous familial hypercholesterolemia.

This patient population includes those who have comorbidities such as hypertension and diabetes and have not yet had a first cardiovascular event.

"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 therapy1,3,4. 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 arm1. 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.

About Leqvio

Leqvio is an injectable prescription medicine indicated as an adjunct to diet and statin therapy for the treatment of adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH), to reduce low-density lipoprotein cholesterol (LDL-C).

Novartis has obtained global rights to develop, manufacture and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals, a leader in RNAi therapeutics.