FDA accepts Regeneron application for evinacumab for cholesterol disorder

Under Priority Review status, the FDA accepts for review Regeneron Pharmaceuticals’ (NASDAQ:REGN) marketing application seeking approval of evinacumab as an adjunct to other lipid-lowering therapies for the treatment of patients with homozygous familial hypercholesterolemia (HoFH), a rare inherited disorder characterized by abnormally high levels of cholesterol in the blood.

The agency’s action date is February 11, 2021.

Evinacumab is a fully human monoclonal antibody that binds to a protein called ANGPTL3 that plays a key role in lipoprotein metabolism via inhibiting two enzymes called lipoprotein lipase and endothelial lipase. It is also being tested in patients with refractory hypercholesterolemia and severe hypertriglyceridemia.

https://seekingalpha.com/news/3604491-fda-accepts-regeneron-application-for-evinacumab-for-inherited-cholesterol-disorder