RBC Comments on Amgen (AMGN) Repatha Data
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March 16, 2015 6:40 AM EDT
Amgen (Nasdaq: AMGN) announced one-year data from prespecified exploratory endpoints of adjudicated cardiovascular events in the Phase 2 (OSLER-1) and Phase 3 (OSLER-2) open-label extension studies of Repatha (evolocumab), a novel investigational low-density lipoprotein cholesterol (LDL-C)-lowering medication. These data were presented today at a Late-Breaking Clinical Trial session at the American College of Cardiology's 64th Annual Scientific Session (ACC.15) and published in the New England Journal of Medicine. A two-year analysis of Repatha safety and tolerability data from the longest proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor trial to date (OSLER-1) was also... More
March 16, 2015 6:22 AM EDT
Regeneron (Nasdaq: REGN) and Sanofi (NYSE: SNY) announced that 18-month (78-week) results of a Phase 3 trial of Praluent (alirocumab), an investigational therapy, involving 2,341 high risk patients with hypercholesterolemia were published online in The New England Journal of Medicine. In the ODYSSEY LONG TERM trial, Praluent 150 mg every two weeks reduced low-density lipoprotein cholesterol (LDL-C or "bad" cholesterol) by an additional 62 percent at week 24 when compared to placebo, the primary efficacy endpoint of the study, with consistent LDL-C lowering maintained over 78 weeks.
"These results demonstrated the durable... More
