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Home » FDA Approves Regeneron’s Evkeeza for Rare High Cholesterol Disorder

FDA Approves Regeneron’s Evkeeza for Rare High Cholesterol Disorder

Regeneron logo
February 17, 2021

Regeneron has secured FDA approval for Evkeeza (evinacumab-dgnb) as an adjunct to other low-density lipoprotein cholesterol (LDL-C) lowering drugs for treating homozygous familial hypercholesterolemia (HoFH), a rare inherited disorder associated with early atherosclerotic disease.

The approval was supported by positive results from a late-stage study showing the drug helped reduce LDL-C levels by 49 percent vs. placebo at 24 weeks.

The FDA granted Evkeeza Breakthrough Therapy designation for HoFH in 2017 and gave it a priority review. The annual wholesale price of the monthly treatment is expected to be $450,000.

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