LEQVIO inclisiran

Drug Class

Small interfering RNA (siRNA) targeting PCSK9

Mechanism

Inclisiran is a double-stranded small interfering RNA (siRNA) that targets PCSK9 mRNA, increasing LDL receptor recycling and lowering circulating LDL cholesterol levels.

Approved Indication

Treatment of primary hypercholesterolemia (including heterozygous familial hypercholesterolemia) or mixed dyslipidemia in adults, as an adjunct to diet and statin therapy or as monotherapy.

What This Means For Patients

Leqvio (inclisiran) is a small interfering RNA (siRNA) therapy approved for patients with high LDL cholesterol (low-density lipoprotein). It works by helping the liver clear cholesterol from the blood, requiring only two injections a year after initial doses. It is approved in mainland China and also accessible in the Boao Lecheng pilot zone.

Regulatory Approvals

• FDA — approved (2021) — label
• EMA — approved (2020) — source
• NMPA — approved (2023) — source

Pivotal Clinical Evidence

• ORION-10 — Ray et al., N Engl J Med 2020 (NCT03399370) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214012s000lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/leqvio
• https://doi.org/10.1056/NEJMoa1912387