The Medicines Company Reaches Enrollment Target for ORION-10 Ahead of Schedule

PARSIPPANY, N.J.--(BUSINESS WIRE)--The Medicines Company (NASDAQ: MDCO) today announced that randomization of more than 1,500 patients in the ORION-10 trial in the United States has been completed in only 12 weeks – considerably beating its goal of 22 weeks. ORION-10 is a double-blind, randomized Phase III trial designed to confirm the efficacy and safety of inclisiran, an investigational agent which is potentially a first-in-class lipid-lowering drug to reduce LDL-cholesterol (LDL-C) in patients with atherosclerotic cardiovascular disease (ASCVD). In the trial, patients are randomized to inclisiran sodium 300 mg or placebo given subcutaneously on days 1, 90, 270 and 450 – then followed to the end of the study at day 540 (18 months). ORION-10 is one of three similar trials designed to confirm inclisiran safety and efficacy and will provide key data required for NDA and MAA submission in the United States and Europe. Two other trials (ORION-9 in heterozygous familial hypercholesterolemia (HeFH) performed in North America, Europe and South Africa, and ORION-11 in ASCVD performed in Europe) completed enrollment earlier this year – also ahead of schedule.