Welcome to the Aegerion Patient Resource area. Here you can find more information about the clinical development of our investigational therapy, lomitapide as well as links to some of the important advocacy, education and support groups who provide information to patients with hypercholesterolemia, hypertriglyceridemia and orphan indications such as HoFH and FC. Corporate members of:
Lipids are naturally occurring molecules that are transported in the blood. Excess levels of lipids such as cholesterol and triglycerides can drastically increase the risk of potentially life threatening cardiovascular events, such as stroke or heart attack or acute pancreatitis. In the case of several rare genetic lipid disorders, patients with extremely high lipid levels are at very high risk of these events at an early age.
Aggressive dietary modification in addition to lipid-lowering therapies such as statins have been shown to reduce the amount of total cholesterol, however the resulting levels, even at maximum tolerated doses, are not effective in reducing the low density lipoprotein (LDL-C) to recommended levels in patients who have HoFH or who otherwise don’t respond to statin treatment. In many cases plasma-apheresis, a mechanical filtration used to temporarily remove lipids from the blood is also employed but lipid levels still typically return to their previous high levels.
In the first quarter of 2012, Aegerion submitted an NDA to the FDA, and an MAA to the EMA, requesting approval to market lomitapide, as an adjunct to a low-fat diet and other lipid-lowering therapies, to reduce cholesterol in adult patients with HoFH. Both filings have been accepted and are under review. The FDA has informed Aegerion that the NDA is subject to standard review.
Aegerion anticipates initiating a clinical program of lomitapide as a potential treatment of adult HoFH patients in Japan and initiating trials of lomitapide in pediatric HoFH patients and Familial Chylomicronemia (FC) in 2013. You can learn more about our clinical trials or register to receive clinical updates.
© 2012 Aegerion Pharmaceuticals, Inc. All rights reserved. AEGR/Global/041 12-12