FDA Approves Aegerion's Cholesterol Drug Juxtapid

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Main Category: Regulatory Affairs / Drug Approvals
Also Included In: Cholesterol
Article Date: 26 Dec 2012 - 0:00 PST Current ratings for:
FDA Approves Aegerion's Cholesterol Drug Juxtapid

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:

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.

Written by Kelly Fitzgerald
Copyright: Medical News Today
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posted by nomad on 25 Dec 2012 at 12:14 pm

For some reason, I can't shake the feeling that pharmaceutical companies own the FDA..

Making up fake diseases with long confusing names instead of telling people the simple truth, that our ancestors walked and ran at least 10 miles a day every day for a million years; thus our bodies are tuned to work properly only if we walk and run relatively long distances every day. (This is an evolutionary fact. Fish gotta swim and land predators gotta run.)

So, what happens when we don't? Cholesterol and all that other mumbo jumbo. Don't want to be fat? Run 5-6 kms a day; It'll only take an hour away from your 4 hours a day of TV time. (Go ahead, deny it.)

Here's to good health.. and the pharmaceuticals that are making it possible for everyone.

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posted by les on 25 Dec 2012 at 6:47 am

SAY NO TO POISON!You dont need poison.apple cider vinegar lowers cholesterol guaranteed!

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posted by barry on 25 Dec 2012 at 6:35 am

OK we need ground breaking drugs to save lives, thats the accepted norm of our society today, but $300K/Yr? How can they justify that they made a life saving drug, yet to be seen mind you, only for the rich! I guess the rest of us will just have to settle for our mediocre Lipitor and die a slow death`

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