CHMP recommends Evkeeza to treat adult and adolescent patients aged 12 years and older with homozygous familial hypercholesterolaemia.- Regeneron

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation under exceptional circumstances for the medicinal product Evkeeza, from Regeneron, intended for the treatment of adult and adolescent patients aged 12 years and older with homozygous familial hypercholesterolaemia (HoFH).Evkeeza will be available as concentrate for solution for infusion (150 mg/ml). The active substance of Evkeeza is evinacumab, a monoclonal antibody belonging to the therapeutic class of lipid modifying agents (ATC code: C10AX). It reduces LDL-C cholesterol (LDL-C) level independent of the presence of the LDL receptor by promoting very low-density lipoprotein (VLDL) processing and VLDL remnants clearance upstream of LDL formation.The benefits of Evkeeza are its ability to reduce LDL-C. The most common side effects are nasopharyngitis, influenza like illness, dizziness, back pain and nausea.