The FDA has updated the LEQVIO® (inclisiran) label to include language recognizing that lowering LDL-C reduces the risk of major adverse cardiovascular events (MACE) in adults at increased cardiovascular risk 1.
This update reflects the established scientific evidence from statins or monoclonal antibody proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitors as an add-on to statin therapy, supporting LDL-C reduction as an important component of cardiovascular risk management. It also provides relevant context for the treatment of hypercholesterolemia2. Novartis believes this reinforces the importance of achieving and maintaining recommended LDL-C levels in patients at increased cardiovascular risk.
Novartis continues to advance the VictORION clinical trial program, one of the largest clinical trial programs of its kind, with over 60,000 patients enrolled across more than 30 trials in more than 50 countries. The program includes ORION-4 and VICTORION-2-PREVENT, two major secondary prevention cardiovascular outcomes trials expected to read out in 20273,4. Novartis remains committed to advancing cardiovascular disease prevention and addressing the unmet needs of patients at increased cardiovascular risk.
About Leqvio
LEQVIO (inclisiran) is an injectable prescription medicine used along with diet and exercise to reduce low-density lipoprotein (LDL-C) or “bad” cholesterol in adults with high blood cholesterol levels called hypercholesterolemia; adults and children aged 12 years and older with a type of high blood cholesterol called heterozygous familial hypercholesterolemia (HeFH); and children aged 12 years or older with a type of high blood cholesterol called homozygous familial hypercholesterolemia (HoFH).
Novartis has obtained global rights to develop, manufacture and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals, a leader in RNAi therapeutics.
Important Safety Information
Do not use if you have had an allergic reaction to LEQVIO or any of its ingredients.
Serious allergic reactions can occur. Seek medical help right away if you have difficulty breathing or swallowing; swelling of the face, lips, tongue or throat; dizziness and feel faint; decrease in blood pressure; severe skin itching, with a red rash or raised bumps.
The most common side effects of LEQVIO were: injection site reaction (including pain, redness, and rash), joint pain, and chest cold. The side effects seen in children aged 12 years and older with HeFH or HoFH were similar to adults with hypercholesterolemia, except headaches were more common in children with HeFH.
These are not all the possible side effects of LEQVIO. Ask your health care provider for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch ↗, or call 1-800-FDA-1088.
Please click here for Leqvio full Prescribing Information.