Novartis twice yearly Leqvio (inclisiran) receives FDA approval for new indication enabling first-line use

Novartis

31 July 2025 - 4 out of 5 atherosclerotic cardiovascular disease patients do not reach guideline-recommended LDL-C target, reinforcing urgent need for more aggressive LDL-C lowering.

Novartis announced today that the US FDA has approved a label update for Leqvio (inclisiran), enabling its use as monotherapy along with diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolaemia.

Read Novartis press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Registration