Policy & Regulation
ORION-9 Study of Inclisiran in HeFH Patients Showed Durable and Potent LDL-C Lowering with Twice-Yearly Dosing
19 November 2019 - - US-based biopharmaceutical company The Medicines Company (NASDAQ: MDCO) has released detailed results from ORION-9, the last of three pivotal 18-month low-density lipoprotein cholesterol (LDL-C) lowering Phase 3 clinical studies of inclisiran, an investigational twice-yearly therapy to reduce LDL-C and the first and only cholesterol-lowering treatment in the siRNA (small-interfering RNA) class, the company said.
In ORION-9, twice-yearly dosing (following initial and three-month doses) with inclisiran sodium 300 mg met all primary and secondary efficacy endpoints, was well-tolerated and demonstrated an excellent safety profile.
Full study results were presented during a late-breaking science session at the American Heart Association Scientific Sessions in Philadelphia.
For the primary endpoints of ORION-9, inclisiran delivered placebo-adjusted LDL-C reductions of 50% (71 mg/dL, p
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