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Could Evkeeza’s New Peds Approval Result in a PRV for REGN?
Regeneron announced FDA has accepted the Evkeeza (evinacumab) sBLA for the treatment of homozygous familial hypercholesterolemia (HoFH) in children ages 5 to 11 with a PDUFA date of March 30, 2023. Recall, in February 2021, Evkeeza received FDA approval for the treatment of HoFH in patients 12 years of age and older (previous FENIX insight). Below, FENIX wonders if the approval could result in a PRV.