Positive Phase III results for Novartis twice-yearly Leqvio

Novartis (NOVN: VX) today announced positive top-line results from twice-yearly Leqvio (inclisiran) in the Phase III V-MONO study, which met its primary endpoints.

The Swiss pharma giant noted that 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 said it 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).