Regeneron's Evkeeza Reduces Bad Cholesterol By 48% In Children Aged 5-11 Years

Regeneron Pharmaceuticals Inc REGN announced positive results from a Phase 3 trial evaluating Evkeeza (evinacumab) in children aged 5 to 11 with homozygous familial hypercholesterolemia (HoFH).
HoFH is a disorder where it is hard for the body to remove LDL "bad" cholesterol from the blood, raising the chances of a heart attack at an early age.
The trial met its primary endpoint. It showed that children who added Evkeeza to other lipid-lowering therapies reduced their low-density lipoprotein-cholesterol (LDL-C) by 48% at week 24 on average.
Regulatory submission to the FDA is expected later this year.
Despite treatment with other lipid-lowering therapies, children (n=14) entered the trial with an average LDL-C level of 264 mg/dL, more than twice the target (<130 mg/dL) for pediatric patients with HoFH.
After 24 weeks of Evkeeza treatment, 79% of patients reduced their LDL-C by at least half. On average, an absolute 132 mg/dL reduction in LDL-C from baseline.
Evkeeza was generally well-tolerated, with all patients completing the trial. The most common adverse events (AEs) were throat pain (21%) as well as upper abdominal pain, diarrhea, headache, and nasopharyngitis (all 14%).
Two severe AEs (aortic stenosis and tonsilitis) were reported, both considered unrelated to treatment.
Evkeeza is approved in the U.S. and European Commission as an adjunct therapy for certain patients aged 12 years and older with HoFH.
Regeneron is responsible for developing and distributing Evkeeza in the U.S. and is collaborating with Ultragenyx Pharmaceutical Inc RARE to clinically develop, commercialize, and distribute Evkeeza outside of the U.S.
Price Action: REGN shares closed higher by 0.61% at $661.14 on Friday.

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