Aegerion Pharmaceuticals Inc. said Monday that the Food and Drug Administration approved its drug Juxtapid, a treatment for a rare inherited disease that causes extremely high levels of bad cholesterol.
The FDA approved Juxtapid as a treatment for homozygous familial hypercholesterolemia. The drug is intended to be used along with a low-fat diet and other methods intended to reduce "bad" LDL cholesterol.
Juxtapid is Aegerion's first approved drug, and the company's shares have been trading near all-time highs as investors waited for the FDA's decision. The stock is up 84 percent since Oct. 11 and closed at $25.71 Friday. In premarket trading the shares picked up 3 cents to $25.74.
Aegerion believes there are about 3,000 people in the U.S. with homozygous familial hypercholesterolemia, and treatments like blood filtration are generally not effective. The company said patients often die by the age of 30 because of heart attacks or strokes brought on by the disease.
The availability of Juxtapid, or lomitapide, will be restricted because of the risk of liver damage in patients.