US FDA Grants Expanded Indication to Novartis' Leqvio® (Inclisiran) for Treating High LDL-C in Adults at Increased Risk of Heart Disease

Monday, July 10, 2023

Novartis has announced that the US Food and Drug Administration (FDA) has granted approval for an expanded label for Leqvio® (inclisiran). The updated label allows for earlier use of Leqvio in patients with elevated LDL-C levels who are at an increased risk of heart disease. This includes individuals with comorbidities such as hypertension and diabetes who have not yet experienced their first cardiovascular event.

Victor Bulto, President of Novartis Innovative Medicines US, expressed the company's commitment to addressing the growing burden of cardiovascular disease, which affects a significant number of Americans. Bulto stated that high LDL-C is a modifiable risk factor for heart disease, and the updated label for Leqvio will help reach more patients who struggle to lower their LDL-C levels.

Leqvio, the first and only small interfering RNA (siRNA) therapy approved by the FDA to lower LDL-C, was initially approved in December 2021. The expanded indication allows Leqvio to be used as an adjunct to diet and statin therapy in the treatment of primary hyperlipidemia in addition to the previously approved indications for atherosclerotic cardiovascular disease (ASCVD) and heterozygous familial hypercholesterolemia (HeFH).

Clinical trials have demonstrated that Leqvio provides effective and consistent LDL-C lowering of up to 52% compared to placebo for patients with heart disease or an increased risk of heart disease who are unable to reach their LDL-C target with statin therapy. With a dosage regimen of two doses per year after the initial two doses, Leqvio offers convenience and ensures patients won't miss a dose for six months after administration by a healthcare provider.

The label update removes the Limitations of Use statement and streamlines the safety section by eliminating four adverse events that occurred at a frequency similar to the placebo arm. The label update is effective immediately in the US and underscores the robust safety and efficacy data generated by the VictORION clinical trial program, which comprises over 20 trials and aims to provide comprehensive data for Leqvio.






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