Regeneron Gets FDA Priority Review of Evinacumab

By Colin Kellaher

Regeneron Pharmaceuticals Inc. on Wednesday said the U.S. Food and Drug Administration granted priority review to its biologics license application for evinacumab in patients with an ultra-rare inherited form of high cholesterol.

The Tarrytown, N.Y., biotechnology company is seeking approval of evinacumab as an adjunct to other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia.

The FDA grants priority review to medicines that have the potential to provide significant improvements in the treatment of a serious disease, and the designation shortens the review period to six months from the standard 10 months. Regeneron said the agency set a target action date of Feb. 11, 2021, for the application.

Regeneron said homozygous familial hypercholesterolemia affects about 1,300 patients in the U.S., the vast majority of whom are unable to reach target low-density lipoprotein cholesterol levels with currently available therapies.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

August 12, 2020 07:46 ET (11:46 GMT)

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