FDA Approves Aegerion's Cholesterol Drug Juxtapid

Editor's Choice
Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Cholesterol
Article Date: 25 Dec 2012 - 1:00 PST

Aegerion Pharmaceuticals announced that the U.S. Food and Drug Administration has approved use of Juxtapid (lomitapide) pills as an accompaniment to a low-fat diet and other lipid-lowering treatments.

Juxtapid is for patients with homozygous familial hypercholesterolemia (HoFH), a critical, uncommon genetic disease that inhibits the function of the receptor that eliminates bad cholesterol from the body. This loss of function of the LDL receptor function causes high levels of cholesterol in the blood.

HoFH is characterized by untimely atherosclerosis, a blocking of the arteries and can result in heart attacks at an early age.

Katherine Wilemon, president and founder of The FH Foundation. says:

"The FDA approval of JUXTAPID is a major step forward for HoFH patients and their families, who have long been waiting for new therapies. New treatments, combined with further understanding and awareness of this disease, can bring much needed hope to the HoFH community."

Juxtapid has a warning label, known as a "boxed warning", the strongest warning a drug can carry, and will only be available through a restricted program because of its liver damage risks.

The approval was based on Aegerion's Phase III study which examined the effectiveness and safety of Juxtapid. When used in combination with current lipid-reducing therapy, Juxtapid helped decrease LDL cholesterol from an average of 336 mg/dL to 190 mg/dL, a 40 percent drop.

The most common side effects were gastrointestinal issues. Frequent reactions included:

• nausea
• vomiting
• diarrhea
• dyspepsia
• constipation
• flatulence
• chest pain
• influenza
• fatigue
• abdominal discomfort

These drug injections could cost up to $300,000 each year and will require strict safety measures.

This drug is Aegerion's first on the market and FDA will decide whether or not to accept a similar drug made by Sanofi and Isis Pharmaceuticals Inc. called Kynamro.

Risks Associated With High Cholesterol

• narrowing of the arteries
• chest pain or discomfort
• stroke or mini-stroke
• heart attack
• higher coronary heart disease risk

Written by Kelly Fitzgerald
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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