Amgen’s PCSK9 inhibitor drug Repatha (evolocumab) does not have an effect on cognitive function, according to the results from a recent Phase III clinical trial. The results of the EBBINGHAUS study were published in the New England Journal of Medicine (NEJM).
The cognitive function trial involved nearly 2,000 patients from Amgen’s cardiovascular outcomes trial, FOURIER. This larger trial included almost 30,000 patients with high cholesterol and atherosclerotic cardiovascular disease.
“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 lead study investigator Dr. Robert P. Giugliano, Brigham and Women’s Hospital, Boston. “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 primary endpoint of the trial assessed changes in executive function in participants taking Repatha and found that it was non-inferior to the placebo. In addition, no statistically significant differences in working memory, memory function or psychomotor speed were observed between the treatment and placebo groups.
“Historically, the clinical cardiology community has had concerns that low LDL-C levels may impact cognitive function,” said Dr. Sean E. Harper, 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.”
Repatha is approved in over 50 countries, with the PCSK9 class of drugs generating much excitement in the field of cardiovascular medicine. Sanofi and Regeneron’s Praluent (alirocumab) is also a member of the drug class, representing significant competition for Amgen’s Repatha.
US sales of Repatha totaled $101 million in 2016, with some analysts predicting that both Repatha and Praluent could bring in a combined $3 billion in sales by 2022.