Amgen Release: Repatha (Evolocumab) Phase III Cognitive Function Study Results Published In The New England Journal of Medicine

THOUSAND OAKS, Calif., Aug. 16, 2017 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that the New England Journal of Medicine (NEJM) published results from the Repatha® (evolocumab) cognitive function trial (EBBINGHAUS), which was conducted in a subset of patients enrolled in the randomized, placebo-controlled Repatha cardiovascular outcomes study (FOURIER). The study demonstrated that Repatha was non-inferior to placebo, with no significant difference in cognitive function between the Repatha and placebo-treated groups.

"In the first prospectively designed study of cognitive function with a PCSK9 inhibitor using validated instruments, we showed that there were no significant differences between patients taking evolocumab and those on placebo," said Robert P. Giugliano, M.D., S.M., Brigham and Women's Hospital, Boston and lead study investigator. "These findings are reassuring for both physicians and patients because they show that LDL cholesterol levels can be lowered with evolocumab to levels well below current treatment targets, with no negative effects on memory or other cognitive domains."

The effect of Repatha on executive function (primary endpoint) was non-inferior to placebo, and there was no statistical difference between Repatha and placebo on the other cognitive domains tested: working memory, memory function and psychomotor speed (secondary endpoints).

"Historically, the clinical cardiology community has had concerns that low LDL-C levels may impact cognitive function," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Across our comprehensive clinical trial program, thousands of patients have been treated with Repatha, which has demonstrated a consistent safety profile, even at very low LDL cholesterol levels. These findings add to the body of evidence supporting the safety of LDL-lowering with Repatha in patients with established cardiovascular disease who need more than statin therapy alone."

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