Aegerion Has Cholesterol Drug Approved by FDA

On Monday, the U.S. Food and Drug Administration said it approved Juxtapid, an Aegerion Pharmaceutical drug that is used to treat a very rare cholesterol disease. Due to the potential toxicity in the user’s liver, the drug requires a safety precaution on the label.

Juxtapid is Aegerion’s first drug to be approved by the FDA. The company’s investors will now get the chance to see how well the company is able to navigate the challenges it will face in the marketing and sales for the drug.

The warning label for Juxtapid will be prominently displayed and there are other requirements needed before patients can use the medication and that could cause up to a four-month wait before being received.

Aegerion CEO Marc Beer said the requirements were consistent with what the company proposed to the U.S. regulatory agency. The label with the warnings will make sure of the safety of the users and the long-term successful adoption of the medication. Beer believes the FDA was correct in approving the drug and understands the rare disease.

The drug is designed to help patients who suffer from homozygous familial hypercholesterolemia also known as HoFH. The rear disorder causes a build up of potentially fatal amounts of LDL-C or bad cholesterol.

There are an estimated 3,000 people in the United State who could benefit from the use of the drug. Annual cost for the medication is expected to reach up to $300,000 per patient.