Novartis' Cholesterol-Lowering Drug Shows Encouraging Outcome In Late-Stage Study

Wednesday, Novartis AG NVS released topline results from twice-yearly Leqvio (inclisiran) in the Phase 3 V-MONO study, which met its primary endpoints.

V-MONO is part of the 60,000-patient VictORION clinical trial program assessing Leqvio for primary and secondary ASCVD prevention.

Also Read: Siemens Healthineers To Buy Novartis Diagnostics To Bolster Cancer Scan Business In $220M Deal.

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 therapy.

Ezetimibe is the most commonly used nonstatin agent, which lowers LDL-C levels by 13% to 20%.

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 continues to advance multiple studies evaluating the potential use of Leqvio across primary and secondary prevention.

• VICTORION-1-PREVENT 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 and American Heart Association guidelines; this outcomes study is expected to complete enrollment later this year.
• In the secondary prevention setting, the ORION-4 and VICTORION-2-PREVENT outcomes studies remain on track for data readouts in 2026 and 2027, respectively.

Today, Lindy Biosciences announced a multi-target exclusive global licensing agreement and strategic collaboration with Novartis Pharma AG, a subsidiary of Novartis.

The collaboration will focus on transitioning select medicines from the Novartis portfolio to convenient, self-administered subcutaneous injections using Lindy Biosciences’ proprietary microglassification suspension technology.

The technology delivers high concentrations of biologics, significantly increasing the maximum dose that can be administered in a single subcutaneous injection.

The agreement’s financial terms include an upfront payment of $20 million to Lindy Biosciences. Lindy Biosciences is also eligible to receive up to $934 million in additional milestone payments.

Price Action: At the last check on Wednesday, NVS stock was up 0.17% to $120.04.

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