FDA Approval of LEQVIO(R) (inclisiran)

By ASPC | January 7, 2022

Novartis has announced that LEQVIO® (inclisiran) has been approved by the FDA for patients with atherosclerotic cardiovascular disease (ASCVD) who need to further lower their bad cholesterol, despite being on a maximally tolerated statin. If interested, the LEQVIO full prescribing information can be found here: https://www.novartis.us/sites/www.novartis.us/files/leqvio.pdf

Novartis is committed to continuing their work with the cardiovascular disease (CVD) community as the needs of people with CVD evolve, ensuring you have the information needed to answer questions as they arise.

What is LEQVIO?

LEQVIO (inclisiran) is an injectable prescription medicine used along with diet and other lipid-lowering medicines in adults who need additional lowering of “bad” cholesterol (LDL-C) and have known cardiovascular disease and/or heterozygous familial hypercholesterolemia (HeFH), an inherited condition that causes high levels of LDL-C. It is not known if LEQVIO can decrease problems related to high cholesterol, such as heart attacks or stroke.

Important Safety Information

The most common side effects of LEQVIO were: injection site reaction (including pain, redness and rash), joint pain, urinary tract infection, diarrhea, chest cold, pain in legs or arms and shortness of breath.

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 see LEQVIO full Prescribing Information.

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