Regeneron Gets Priority Review for Investigational High Cholesterol Drug

The FDA has granted Regeneron’s evinacumab a priority review as an adjunct to other lipid-lowering therapies for the treatment of a rare inherited form of high cholesterol, homozygous familial hypercholesterolemia.

The company supported its biologics license application with results from a phase 3 trial in which patients who received evinacumab along with lipid-lowering therapies reduced their low-density lipoprotein (LDL) cholesterol by 49 percent at 24 weeks.

The FDA is expected to make a decision on the drug’s approval by Feb. 11, 2021.