The U.S. FDA approved a label update for Novartis’ Leqvio (inclisiran) for 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 had a 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.

With two doses a year, after two initial doses, Leqvio was shown to provide 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. 

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. This label update is based on the VictORION clinical trial program, one of the largest cardiovascular clinical trial programs with more than 20 trial, and is designed for consistent and comprehensive data generation.