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FDA Approves Regeneron’s Evkeeza for Rare High Cholesterol Disorder
Drugs Submissions and Approvals
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.