The FDA has acceptedRegeneron Pharmaceuticals Inc’sREGN supplemental marketing application seeking approval for Evkeeza (evinacumab-dgnb) as an adjunct to other lipid-lowering therapies for children aged 5 to 11 years with homozygous familial hypercholesterolemia (HoFH).
The FDA target action date is March 30, 2023.
HoFH is an ultra-rare inherited condition that occurs when two copies of the FH-causing genes are inherited, resulting in dangerously high levels of low-density lipoprotein-cholesterol (LDL-C or bad cholesterol).
The application is supported by data from a three-part trial evaluating Evkeeza in children aged 5 to 11 years with HoFH.
The trial met its primary endpoint, showing that on average, children who added Evkeeza to other lipid-lowering therapies reduced their LDL-C by 48% at week 24.
Furthermore, 79% (n=11) saw their LDL-C reduced by at least half at 24 weeks following Evkeeza treatment, with an average absolute reduction in LDL-C from baseline of 132 mg/dL.
Evkeeza is the first angiopoietin-like 3 (ANGPTL3) targeted therapy approved by the FDA, European Commission, and the U.K.’s Medicines and Healthcare products Regulatory Agency as an adjunct therapy for patients aged 12 years and older with HoFH.
Price Action: REGN shares are up 0.23% at $737.75 on the last check Wednesday.
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