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Is Leqvio FDA approved as a high cholesterol treatment?

Medically reviewed by Carmen Pope, BPharm. Last updated on April 4, 2024.

Official answer

by drugclasses.com

Leqvio is FDA approved as a high-cholesterol treatment and it specifically lowers LDL cholesterol levels (sometimes referred to as "bad" cholesterol). It is approved for people with atherosclerosis (hardening and narrowing of the arteries caused by a build-up of fatty plaques) or heterozygous familial hypercholesterolemia (a genetic condition that causes high levels of LDL cholesterol). Leqvio may be prescribed alone or in addition to statins or other cholesterol-lowering medications.

References
  • Leqvio FDA Approval History. Updated Dec 27, 2021.  https://www.drugclasses.com/history/leqvio.html
  • Lamb Y. N. (2021). Inclisiran: First Approval. Drugs, 81(3), 389–395. https://doi.org/10.1007/s40265-021-01473-6

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What is the difference between Leqvio and Repatha?

Leqvio and Repatha are both injectable medicines that are used for the treatment of high cholesterol, by specifically lowering low density lipoprotein (LDL) levels. Although they both inhibit PCSK9 they work by different mechanisms. Repatha is a monoclonal antibody that binds directly to PCSK9 in the liver preventing it from binding to LDL receptors. Leqvio blocks the PCSK9 protein by interfering with the translation of PCSK9 messenger RNA. Both have the same result – and that is freeing up LDL receptors on the surface of liver cells which allows LDL cholesterol to be removed from the blood. Continue reading

What are PCSK9 Inhibitors and how do they work?

The PCSK9 inhibitors are used for the treatment of high-risk patients with elevated cholesterol, especially when statins aren't adequate. They work by blocking PCSK9, leaving more receptors available to capture your "bad" cholesterol (LDL) for break down and removal from the blood. Continue reading

Can Leqvio be taken without a statin?

Leqvio may be used alone or with other medications, such as statins, to treat high cholesterol, in addition to a heart-healthy diet. But it can be prescribed without a statin if statins are not tolerated or contraindicated. Continue reading

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