If approved, Lojuxta will be indicated for adult patients with homozygous familial hypercholesterolemia (HoFH) in all 27 European Union member countries.
The medication will be an added therapy to a low-fat diet and other lipid-lowering medicinal products with or without low density lipoprotein (LDL) apheresis in HoFH patients.
Aegerion chief executive officer Marc Beer said Lojuxta’s positive CHMP opinion is a milestone for HoFH patients in the EU that can bring their LDL-C levels to goal.
"We will continue to prepare for commercial launch in the EU on a country-by-country basis, and look forward to delivering this important new medicine to patients in need in the EU," Beer added.