FDA updates Leqvio label to recognize cardiovascular outcomes benefits

Novartis/Leqvio

The FDA updated Leqvio's labeling to include language recognizing that lowering LDL-C reduces the risk of major adverse cardiovascular events (MACE) in adults at increased cardiovascular risk. The update reflects established evidence from statins and PCSK9 inhibitor studies.

• FDA added MACE reduction language based on LDL-lowering evidence from statins and monoclonal antibody PCSK9 inhibitors.
• Reflects data from cardiovascular outcomes trials demonstrating LDL-C reduction benefits.
• Supports LDL-C lowering as part of cardiovascular risk management strategy.
• Novartis advancing ORION-4 and VICTORION-2-PREVENT outcomes trials expected to read out 2027.