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 is not distributed through mainland China's retail pharmacy network. Uwell Cloud can help arrange a purchase channel for this medicine, sourced and dispatched from Hong Kong; clinical administration support in China can be coordinated on request. Availability and eligibility for any specific patient are determined by clinical review.

Regulatory Approvals

• FDA — Approved (2021) — Sources
• EMA — Approved (2020) — Sources
• NMPA — Approved (2023) — Sources

Pivotal Clinical Evidence

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

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