Federal regulators have approved Aegerion Pharmaceuticals' treatment for a rare inherited disease that causes extremely high levels of bad cholesterol, the company said Monday.
The company's shares have been hitting annual highs but declined in early trading after the Food and Drug Administration approval of Juxtapid, Aegerion's first drug, was announced.
The availability of the drug will be restricted because of the risk of liver damage in patients and the box will carry a "black box" warning, the FDA's most severe safety warning. Aegerion must certify all health care providers that prescribe it.
Juxtapid is a treatment for homozygous familial hypercholesterolemia in conjunction with other measures to reduce "bad" LDL cholesterol.
Aegerion believes there are about 3,000 people in the U.S. with the disease 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.
A year of treatment is expected to cost between $200,000 and $300,000 for patients with commercial health insurance. Aegerion plans to start selling Juxtapid in January.
Shares of Aegerion Pharmaceuticals Inc. , based in Cambridge, Mass., fell 46 cents to $25.25, and earlier it declined as much as 7 percent. The stock reached a new 52-week high of $25.74 Friday, and it is up about 80 percent since Oct. 11.