For research and educational purposes only. Not medical advice.
Inclisiran Reference
Educational, not medical advice reference for Inclisiran: Metabolic; regulatory status, evidence posture, source review, and schedule notes. Also known as Le…
Reference summary
ORION-10 (n=1,561, US patients with ASCVD) and ORION-11 (n=1,617, European patients with ASCVD or ASCVD-risk-equivalent) were pooled and published in Ray 2020 NEJM. Both trials reported approximately 50 percent reduction in LDL-C from baseline at day 510 versus placebo with twice-yearly maintenance dosing. The cardiovascular outcomes trial ORION-4 (n=15,000+) was designed but has not yet reported.
Regulatory and posture
- Categories
- Metabolic
- Aliases
- Leqvio, ALN-PCSsc, Small interfering RNA targeting PCSK9 mRNA
- Evidence posture
- human - LDL-C reduction is well-characterized; cardiovascular outcome trial (ORION-4) has not yet reported.
- Regulatory status
- FDA-approved as Leqvio (2021) as an adjunct to diet and maximally tolerated statin therapy for adults with HeFH or established atherosclerotic cardiovascular disease requiring additional LDL-C lowering.
- Content review status
- label verified