Skip to main content

Is Leqvio FDA approved as a high cholesterol treatment?

Medically reviewed by Carmen Pope, BPharm. Last updated on Sep 23, 2025.

Official Answer by Drugs.com

Yes, Leqvio is FDA approved as a high-cholesterol treatment and it specifically lowers LDL cholesterol levels (sometimes referred to as "bad" cholesterol).

Leqvio is used with diet and exercise to reduce LDL cholesterol in adults with high cholesterol, including those with familial hypercholesterolemia.

Leqvio is an injection given subcutaneously (under the skin) by a healthcare provider 2 times a year.

References
  • Leqvio Prescribing Information. https://www.novartis.com/us-en/sites/novartis_us/files/leqvio.pdf
  • Lamb Y. N. (2021). Inclisiran: First Approval. Drugs, 81(3), 389–395. https://doi.org/10.1007/s40265-021-01473-6

Read next

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 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?

Yes, Leqvio can be prescribed without a statin and is FDA-approved for first-line use without a statin.

Continue reading

See also:

Related medical questions

Drug information

Related support groups