Evinacumab (1) – Evkeeza®

• Clinical trials
  • The randomised, controlled, double-blind ELIPSE-HoFH trial investigated the administration of evinacumab versus placebo, in each case in combination with a low-fat diet and maximally tolerated lipid-lowering therapy, in 65 adults and adolescents aged 12 years and over diagnosed with homozygous familial hypercholesterolaemia (HoFH).

Adolescents aged 12 years and over and adults with homozygous familial hypercholesterolaemia in whom dietary and pharmacological options for lipid-lowering therapy have been exhausted

• The additional benefit is not proven.
• In summary, the additional benefit of evinacumab over the appropriate comparator therapy is not proven in this patient group.
• As a significant proportion of patients in the comparator arm of the presented ELIPSE-HoFH study received neither evolocumab nor LDL apheresis, the appropriate comparator therapy was not adequately implemented in the study, and the study cannot be used to establish additional benefit.
• Furthermore, a longer duration of the ELIPSE-HoFH study would have been advisable for assessing the long-term effects of evinacumab in this indication.
• The single-arm study R1500-CL-1719, presented as supplementary evidence, is not suitable for drawing conclusions regarding the additional benefit of evinacumab compared with the appropriate comparator therapy due to the lack of a comparator.

Courtesy translation only, please refer to the German original.