The label update reinforces the safety and effectiveness data of Leqvio generated by the VictORION clinical trial programme, claimed the company.
Leqvio was initially approved by the FDA in December 2021.
It is claimed to be the first and only small interfering RNA (siRNA) therapy to reduce LDL-C.
The updated indication for primary hyperlipidemia enables the expanded use of Leqvio as an adjunct to diet and statin therapy beyond the earlier approved atherosclerotic cardiovascular disease (ASCVD) and heterozygous familial hypercholesterolemia (HeFH).
With two doses annually, following two initial doses, LDL-C levels were found to be lowered by up to 52% against placebo in patients with increased risk of heart disease and who were unable to reach their LDL-C target despite statin therapy.
Novartis Innovative Medicines US president Victor Bulto said: “Novartis is committed to addressing the rising burden of cardiovascular disease, a substantial public health burden affecting 30 million Americans.
“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.”
Among the other updates to the label include the removal of the Limitations of Use statement.
Furthermore, the safety section was streamlined to eliminate four adverse events given that the frequency of these events were the same as the placebo arm.
Under a license and collaboration agreement with Alnylam Pharmaceuticals, Novartis gained worldwide rights to develop, manufacture and commercialise Leqvio.
Leqvio is an injectable prescription medicine that is indicated as an adjunct to diet and statin therapy.
It is used for treating adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH) to lower low-density lipoprotein cholesterol (LDL-C).