Regeneron: FDA Approves Evkeeza in Rare Form of High Cholesterol

By Michael Dabaie

Regeneron Pharmaceuticals Inc. said the U.S. Food and Drug Administration approved Evkeeza for patients with an ultra-rare inherited form of high cholesterol.

Regeneron said the FDA approved Evkeeza as an adjunct to other low-density-lipoprotein-cholesterol-lowering therapies to treat adult and pediatric patients aged 12 years and older with homozygous familial hypercholesterolemia.

HoFH is an ultra-rare inherited condition that affects about 1,300 patients in the U.S. HoFH occurs when two copies of the familial hypercholesterolemia-causing genes are inherited, one from each parent, resulting in dangerously high levels of LDL-C, or bad cholesterol, the company said. Patients with HoFH are at risk for premature atherosclerotic disease and cardiac events as early as their teenage years.

In a pivotal Phase 3 HoFH trial, adding Evkeeza to standard lipid-lowering therapies reduced LDL-C by nearly half at 24 weeks, compared to placebo, Regeneron said.

Shares were up 0.4%, to $493.04, in afternoon trading.

Write to Michael Dabaie at michael.dabaie@wsj.com

(END) Dow Jones Newswires

February 11, 2021 14:46 ET (19:46 GMT)

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