Leqvio® shows significant LDL-C reduction as a monotherapy for low/moderate ASCVD risk patients

Källa: Novartis

29 aug 2024

Novartis twice-yearly* Leqvio® demonstrated clinically meaningful, statistically significant LDL-C lowering as a monotherapy in patients at low or moderate ASCVD risk

  • Phase III V-MONO study met its primary endpoints, demonstrating superiority of Leqvio (inclisiran) monotherapy vs both placebo and ezetimibe in LDL-C reduction1
  • Results add to growing body of evidence for Leqvio across the ASCVD continuum
  • Data will be shared with regulatory agencies and presented at an upcoming medical meeting
  • V-MONO is part of the 60,000-patient VictORION clinical trial program assessing Leqvio for primary and secondary ASCVD prevention

Basel, August 28, 2024 – Novartis announced today positive topline results from twice-yearly* Leqvio® (inclisiran) in the Phase III V-MONO study, which met its primary endpoints. Leqvio monotherapy achieved clinically meaningful and statistically significant low-density lipoprotein cholesterol (LDL-C) lowering versus both placebo and ezetimibe in patients who were at low or moderate risk of developing atherosclerotic cardiovascular disease (ASCVD) and not receiving lipid-lowering therapy1.

V-MONO is the first trial evaluating a small interfering RNA (siRNA) therapy taken as monotherapy to lower LDL-C in patients at low or moderate risk of developing ASCVD. Novartis plans to present results from this trial at an upcoming medical meeting and share with regulatory agencies including the US Food and Drug Administration (FDA).

“We are proud that we continue to advance the scientific understanding of using siRNA therapy to tackle one of the world’s biggest healthcare challenges, as too many people still struggle to reach their cholesterol goals,” said Shreeram Aradhye, M.D., President, Development and Chief Medical Officer, Novartis. “This trial adds to the growing body of evidence for Leqvio across the full spectrum of ASCVD as we strive to help more patients in need.”

Novartis continues to advance multiple studies evaluating the potential use of Leqvio across primary and secondary prevention. VICTORION-1-PREVENT (V1P) is the only dedicated study of a non-statin lipid-lowering therapy in a high-risk primary prevention population as defined by American College of Cardiology (ACC) and American Heart Association (AHA) guidelines; this outcomes study is expected to complete enrollment later this year2. In the secondary prevention setting, the ORION-4 and VICTORION-2-PREVENT (V2P) outcomes studies remain on track for data readouts in 2026 and 2027, respectively.

*After an initial dose and another at three months.