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FDA Approves Evolocumab Add-On for Familial Hypercholesterolemia in Children Aged 10 and Older

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eMediNexus    25 September 2021

Evolocumab has been approved by the US Food and Drug Administration (FDA) as add-on treatment to diet alone or with other therapies among children aged 10 years and above having either heterozygous or homozygous familial hypercholesterolemia (FH). 

The approval was based on randomized trials of evolocumab in both heterozygous and homozygous FH. The HAUSER-RCT trial enrolled patients 10 to 17 years of age with heterozygous FH, taking statins with or without ezetimibe. Patients were randomized to monthly subcutaneous injections of evolocumab (420 mg) or placebo for a period of 24 weeks. There was an average 38% reduction in LDL cholesterol among treated patients. The findings were published in the New England Journal of Medicine in August, 2020.  Another trial involving patients aged 11-17 years with homozygous FH noted that patients treated with evolocumab subcutaneous injection (420 mg) monthly given for 80 weeks reported an average 14% reduction in LDL cholesterol, in comparison with the baseline… (Medscape)

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