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Amgen reports positive results from Phase 2 study of PCSK9 inhibitor

Amgen announced results from the Open Label Study of Long TERm Evaluation Against LDL-C trial, a long-term controlled 52-week safety and efficacy study, that showed monthly treatment with evolocumab, an investigational fully human monoclonal antibody that inhibits PCSK9, a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol, or "bad" cholesterol, from the blood1, was not associated with a major increase in adverse events versus standard of care and produced mean LDL-C reductions of 52% in combination with SOC in patients with high cholesterol. These data from the first 52-week study of a PCSK9 inhibitor were presented for the first time in a Clinical Science: Special Reports session at the American Heart Association Scientific Sessions 2013 in Dallas and simultaneously published in Circulation. "Phase 2 findings from OSLER, the first reported 52-week evaluation of a PCSK9 inhibitor, are encouraging and suggest evolocumab may be a promising option to treat hyperlipidemia in a range of at-risk patients," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We look forward to Phase 3 results from our PROFICIO clinical program evaluating the safety and efficacy of two distinctive dosing options of evolocumab in a range of at-risk patient populations."