Novartis Says FDA Approves Expanded Use For Leqvio

(RTTNews) - Novartis AG (NVS) announced Monday 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 therapy.

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

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 populations.

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.