Novartis twice-yearly* Leqvio® (inclisiran) FDA OK for new indication enabling first-line use

Novartis (NYSE:NVS) announced a significant FDA approval for a label update of Leqvio® (inclisiran), enabling its use as a first-line monotherapy for LDL-C reduction in adults with hypercholesterolemia. The update removes the requirement for combination with statin therapy, allowing Leqvio to be used alone with diet and exercise.

The FDA proactively requested this label update based on robust LDL-C lowering data for PCSK9-targeting therapies. This development is particularly significant as up to 80% of ASCVD patients in the US struggle to reach the LDL-C guideline-recommended target of <70 mg/dL. Leqvio's unique twice-yearly dosing regimen, administered by healthcare providers, aims to support better patient adherence and long-term cholesterol management.

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