Novartis Receives FDA Approval for Leqvio for Cardiovascular Risk Reduction

Novartis today announced that the FDA has approved Leqvio (inclisiran sodium) for the reduction of major adverse cardiovascular events in adults with established atherosclerotic cardiovascular disease. The approval was based on results from the Phase 3 ORION-4 trial demonstrating a 26% reduction in MACE compared to placebo, along with a sustained 50% reduction in LDL-C. Leqvio is a twice-yearly subcutaneous siRNA that inhibits PCSK9 synthesis. This approval establishes Leqvio as a cardiovascular risk reduction therapy with a convenient twice-yearly dosing schedule.