Aegerion Pharmaceuticals' Juxtapid (lomitapide) capsules has received US FDA approval to be used as an adjunct to a low-fat diet and other lipid-lowering treatments.
Juxtapid, which is a supplement to fat reduction treatments also includes availability of LDL apheresis, to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B) and non- high-density-lipoprotein cholesterol (non-HDL) in patients with homozygous familial hypercholesterolemia (HoFH).
Aegerion chief executive officer Marc Beer said Juxtapid will be a new curing option for patients with HoFH.
"The approval of our first product also marks an important corporate milestone for Aegerion and reflects our commitment to help patients in need,"Beer added.
The FDA's approval is based on the company's 78 week phase III study, which assessed the safety and effectiveness of the medicine to reduce LDL-C levels in 29 adult patients with HoFH.
HoFH is a genetic disease that damages the function of the receptor responsible to eradicate LDL-C from the body.
