The European Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinion for Aegerion Pharmaceuticals' marketing authorization for Lojuxta (lomitapide) hard capsules.
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.
