Regeneron gets FDA approval for expanded use of high cholesterol drug Evkeeza in kids
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The U.S. Food and Drug Administration (FDA) approved the expanded use of Regeneron Pharmaceuticals' (NASDAQ:REGN) Evkeeza as an adjunct to other lipid-lowering therapies to treat children aged five to 11 years with homozygous familial hypercholesterolemia (HoFH).
HoFH is an ultra-rare form of high cholesterol. The condition is characterized by high levels of low-density lipoprotein cholesterol (LDL-C), also known as 'bad' cholesterol.
In February 2021, Evkeeza (evinacumab-dgnb) was initially approved as an adjunct to other lipid-lowering therapies in patients aged 12 years and older with HoFH .
Regeneron noted that the FDA had granted priority preview to its supplemental biologics license for Evkeeza for the new indication.
Evkeeza had met the main goal of a trial by showing children who received the drug to other lipid-lowering therapies reduced their LDL-C by 48% at week 24 on average.
Regeneron is responsible for developing and distributing Evkeeza in the U.S. and is collaborating with Ultragenyx (NASDAQ:RARE) to develop and sell Evkeeza outside the U.S.