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Regeneron Announces American College of Cardiology Presentation of Positive Phase 3 Evinacumab Results in Patients with Severe Inherited Form of High Cholesterol
TARRYTOWN, N.Y., March 30, 2020 /PRNewswire/ -- Results from separate positive Phase 3 trial of Praluent® (alirocumab) in patients with HoFH also presented;
About this update from Regeneron Pharmaceuticals, Inc.
[{"type":"text","content":"TARRYTOWN, N.Y., March 30, 2020 /PRNewswire/ -- \nResults from separate positive Phase 3 trial of Praluent® (alirocumab) in patients with HoFH also presented; FDA regulatory submission planned for Q2 2020\nRegeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced that detailed Phase 3 results of evinacumab were presented today as a late-breaking presentation at the American College of Cardiology's Annual Scientific Session together with World Congress of Cardiology (ACC.20). Evinacumab is an investigational fully-human monoclonal antibody that binds to and blocks the function of angiopoietin-like 3 (ANGPTL3), in patients with homozygous familial hypercholesterolemia (HoFH). Regeneron previously announced topline positive results of this trial in August 2019. \nHoFH is an inherited disease in which patients have severely elevated levels of bad cholesterol (otherwise known as low-density lipoprotein cholesterol, or LDL-C) and often experience early atherosclerotic disease, sometimes suffering cardiac events in their teenage years. Most patients with HoFH are less responsive (or unresponsive) to standard lipid-lowering therapies, including statins and PCSK9 inhibitors, which act mainly by inducing LDL receptor function, leaving these patients with high unmet need. Evinacumab acts by a different mechanism than other lipid-lowering therapies, raising the possibility that it might offer patients with HoFH profound LDL-C reductions. Supporting this possibility, genetic research has shown that reduction of ANGPTL3 is associated with decreased LDL-C levels, as well as significantly lower risk of coronary artery disease. \nIn this Phase 3 trial, patients who added evinacumab to other lipid-lowering therapies reduced their LDL-C by 49% from baseline at 24 weeks compared to the placebo group, who received other lipid-lowering therapies alone, the primary endpoint of the trial (p","length":2596,"tagName":"div"}]