The US FDA has approved the fully human monoclonal antibody evinacumab-dgnb (Evkeeza, Regeneron Pharmaceuticals) for use on top of other cholesterol-modifying meds in patients aged 12 and older with homozygous familial hypercholesterolemia (HoFH).
Mechanism: Evinacumab-dgnb is a fully-human monoclonal antibody that binds to and blocks the function of ANGPTL3.
Dose: 15 mg/kg) once a month via intravenous infusion.
Adverse Effects: Nasopharyngitis, influenza-like illness, dizziness, rhinorrhea, nausea, pain in extremity and asthenia.
Cost: $450,000 per year
Extra notes: Reductions in LDL-C seen were observed as early as week 2 and maintained throughout the double-blind treatment period (week 24) and open-label trial period (through week 48).