Evinacumab: First Approval

The recombinant human monoclonal antibody evinacumab (evinacumab-dgnb, EVKEEZA (TM)) is an angiopoietin-like protein three (ANGPTL3) inhibitor that has been developed by Regeneron Pharmaceuticals for the treatment of homozygous familial hypercholesterolaemia (HoFH), refractory hypercholesterolemia (both familial and non-familial) and severe hypertriglyceridaemia. Based on the results of the phase III ELIPSE HoFH trial, evinacumab was recently approved in the USA as an adjunct to other LDL-C lowering therapies for the treatment of adult and paediatric patients aged 12 years and older with HoFH, and has received a positive opinion in the EU. This article summarizes the milestones in the development of evinacumab leading to this first approval for HoFH.

Automated summary

Evinacumab, a recombinant human monoclonal antibody, has been approved for the treatment of HoFH and severe hypertriglyceridemia in the USA, and has received a positive opinion in the EU. This milestone in evinacumab's development highlights its efficacy in managing various lipid disorders.