Posted by Michael Wonder on 30 Nov 2022
Evkeeza (evinacumab-dgnb) sBLA for children with ultra rare inherited form of high cholesterol accepted for FDA priority review
30 November 2022 - If approved, Evkeeza would be the first and only treatment of its kind to help children as young as 5 years old control dangerously high levels of LDL-cholesterol caused by homozygous familial hypercholesterolaemia
Regeneron Pharmaceuticals today announced the US FDA has accepted for priority review the supplemental biologics license application for Evkeeza (evinacumab-dgnb) as an adjunct to other lipid-lowering therapies to treat children aged 5 to 11 years with homozygous familial hypercholesterolaemia. The FDA target action date is 30 March 2023.
