FDA approves expanded indication for Novartis Leqvio (inclisiran) to include treatment of adults with high LDL-C and who are at increased risk of heart disease

Novartis announced today 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.

“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 populations.

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 therapy. After administration of Leqvio by a health care provider (HCP), HCPs can be confident that a dose won’t be missed for 6 months.

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. 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.