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

Core Viewpoint - Novartis has received FDA approval for an updated label for Leqvio® (inclisiran), allowing its use as a monotherapy to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, alongside diet and exercise [1][2][3] Group 1: Product Information - Leqvio is now indicated for use as a standalone treatment, removing the previous requirement for combination with statin therapy [3] - The updated label specifies "hypercholesterolemia" instead of "primary hyperlipidemia," focusing on LDL-C reduction [3] - Leqvio is administered twice a year by healthcare providers, which may enhance patient adherence and long-term management of LDL-C levels [2][8] Group 2: Market Need and Impact - Up to 80% of patients with atherosclerotic cardiovascular disease (ASCVD) in the US do not achieve the recommended LDL-C target of less than 70 mg/dL, highlighting a significant unmet medical need [2][8] - The 2025 ACC/AHA guidelines recommend more aggressive treatment strategies to meet LDL-C targets, further emphasizing the importance of Leqvio's new indication [2][8] Group 3: Company Background - Novartis has global rights to develop, manufacture, and commercialize Leqvio through a collaboration with Alnylam Pharmaceuticals, a leader in RNAi therapeutics [4] - The company aims to address critical challenges in cardiovascular disease management and improve patient outcomes through innovative treatments [10][11]