FDA accepts priority review for Regeneron's evinacumab, which could join Praluent in cholesterol market
Almost a year ago to the day, Regeneron announced solid Phase III testing results for evinacumab, a compound that’s designed to lower LDL cholesterol in patients who need treatment beyond a PCSK9 inhibitor. As that anniversary approaches, the biotech is potentially one step closer to putting it on the market.
The FDA has granted priority review and accepted a BLA for evinacumab as a supplement to other lipid-lowering therapies in individuals with homozygous familial hypercholesterolemia, Regeneron announced Wednesday morning. Regeneron’s target action date is next February 11.
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