FDA accepts evinacumab BLA for priority review

US biotech Regeneron Pharmaceuticals (Nasdaq: REGN) saw its shares edge up 2.4% to $613.11 by mid-morning today, as it announced that the US Food and Drug Administration has accepted for priority review a Biologics License Application (BLA) for evinacumab as an adjunct to other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH).

Evinacumab is the first investigational medicine of its kind to show efficacy in patients with HoFH – including patients with little to no low-density lipoprotein (LDL) receptor function – by binding to and blocking the function of angiopoietin-like 3 (ANGPTL3), Regeneron noted.

The target action date for the FDA decision is February 11, 2021. The FDA granted evinacumab Breakthrough Therapy designation in 2017 for the treatment of hypercholesterolemia in patients with HoFH.