Amgen (AMGN), Thursday said that Phase 3 DESCARTES (Durable Effect of PCSK9 Antibody Compared with Placebo Study) trial evaluating the long-term 52-week safety and efficacy of evolocumab for the treatment of high cholesterol met its primary endpoint of percent reduction from baseline in low-density lipoprotein cholesterol.
The mean percent reduction in LDL-C, or 'bad' cholesterol, was consistent with the results observed in the 52-week analysis of the Phase 2 OSLER (Open Label Study of Long Term Evaluation Against LDL-C) study. The DESCARTES trial evaluated safety, tolerability and efficacy in 901 patients with high LDL-C and a range of cardiovascular risk.
Evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove LDL-C from the blood.
"These data contribute to the growing body of research suggesting that evolocumab may offer a new treatment option for patients with dyslipidemia." said Sean Harper, executive vice president of Research and Development of the company.
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