Novartis’ investigational drug, Leqvio (inclisiran), has demonstrated positive results in a Phase III clinical trial. The drug, which is administered twice yearly, significantly lowered low-density lipoprotein cholesterol (LDL-C) levels in patients at low or moderate risk of atherosclerotic cardiovascular disease (ASCVD).
 
The V-MONO study, which evaluated Leqvio as a monotherapy, compared its efficacy to both placebo and ezetimibe, a commonly used cholesterol-lowering medication. Patients enrolled in the trial were not receiving any lipid-lowering therapy at the time.
 
The results of the study are significant as Leqvio is the first small interfering RNA (siRNA) therapy to be evaluated for its ability to lower LDL-C in patients at low or moderate risk of ASCVD. Novartis plans to submit the data to regulatory agencies, including the U.S. Food and Drug Administration (FDA), and present the findings at an upcoming medical meeting.
 
“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 is currently conducting several other studies to evaluate the potential benefits of Leqvio in both primary and secondary prevention of ASCVD. The VICTORION-1-PREVENT (V1P) study is focused on high-risk primary prevention patients, while the ORION-4 and VICTORION-2-PREVENT (V2P) studies are evaluating the drug’s efficacy in secondary prevention.

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