Aegerion Pharmaceuticals, Inc., a biopharmaceutical company dedicated to the development and commercialization of novel, life-altering therapies for patients with debilitating, often fatal, rare diseases, has received the positive European Committee for Medicinal Products for Human Use (CHMP) opinion with a unanimous vote recommending a marketing authorization for Lojuxta (lomitapide) hard capsules. If approved, Lojuxta  will be indicated as an adjunct to a low-fat diet and other lipid-lowering medicinal products with or without low density lipoprotein (LDL) apheresis in adult patients with homozygous familial hypercholesterolemia (HoFH).

The European Commission (EC) needs to ratify the positive opinion from CHMP to grant marketing authorization for Lojuxta in all 27 European Union member countries. A decision is expected from the European Commission in the third quarter of 2013.

"The positive CHMP opinion for Lojuxta  marks a significant milestone for patients in the EU with HoFH who currently have limited treatment options available that can bring their LDL-C levels to goal," said Marc D Beer, chief executive officer of Aegerion. "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."

HoFH is a serious, rare genetic disease that impairs the function of the receptor responsible for removing low-density lipoprotein cholesterol (LDL-C or "bad" cholesterol) from the body. A loss of LDL receptor function results in extreme elevation of blood cholesterol levels. HoFH patients often develop premature and progressive atherosclerosis, a narrowing or blocking of the arteries.

Aegerion Pharmaceuticals is a biopharmaceutical company dedicated to the development and commercialization of innovative, life-altering therapies for patients with debilitating, often fatal, rare diseases.