Novartis Expands Leqvio’s Potential After Successful Phase III Study Demonstrates Significant Cholesterol Reduction

Novartis' Leqvio Demonstrates Efficacy:
The Phase III V-MONO study showed that twice-yearly Leqvio (inclisiran) significantly lowered LDL-C levels in patients at low or moderate risk of developing atherosclerotic cardiovascular disease (ASCVD) who were not receiving lipid-lowering therapy.

Consistent Long-Term Efficacy and Safety:
Long-term data from the ORION-8 open-label extension trial demonstrated that Leqvio, in addition to statin therapy, provided consistent LDL-C reduction beyond six years in patients with ASCVD or increased risk of ASCVD.

Early Addition of Leqvio Improves Outcomes:
The V-INITIATE trial found that early addition of Leqvio to maximally tolerated statin therapy significantly reduced LDL-C levels in ASCVD patients who could not reach their goal on statin therapy alone.

Sustained Efficacy Over Four Years:
The ORION-3 open-label extension trial showed that Leqvio provided effective and sustained LDL-C reduction over four years in patients with ASCVD or ASCVD risk equivalents, and elevated LDL-C despite maximally tolerated statin therapy.

Regulatory and Clinical Trial Progress:
Novartis plans to share the V-MONO study results with regulatory agencies and present them at an upcoming medical meeting. The company continues to advance multiple studies evaluating the potential use of Leqvio across primary and secondary prevention settings.