Pfizer gets EU approval for kids' cholesterol drug

July 6, 2010 By LINDA A. JOHNSON , AP Business Writer

(AP) -- The European Union has approved a new chewable form of cholesterol blockbuster Lipitor for children 10 and up with high levels of bad cholesterol and triglycerides, a type of blood fat, Pfizer said Tuesday.

The approval includes children whose high blood fats are due to an inherited disease that causes extremely high levels, familial hypercholesterolemia.

New York-based Pfizer Inc. won U.S. approval for Lipitor use in children 10 to 17 with that condition in 2002.

Lipitor is the world's top-selling drug, with 2009 sales of about $13 billion, but its U.S. patent expires at the end of November 2011. Pfizer, the world's biggest drugmaker, will quickly lose most Lipitor revenue once generic competition hits, so the company has been trying to boost sales where possible before then.

Pfizer said last fall that it plans to apply for a six-month extension of its patent in European countries, after doing studies of Lipitor in youngsters.

As in the United States, the European Union allows drug makers to seek an additional six months of patent protection for medications if they test them in children, who generally are excluded from the drug studies performed to win approval for a new medication.

already won such an extension for its crucial U.S. patent on Lipitor.

For blockbuster drugs, those extensions can easily bring hundreds of millions of dollars in additional revenue. Normally, they are for drugs that are widely used by different age groups.

Until recently, cholesterol drugs have been primarily taken by adults with heart disease, but their use has expanded to younger patients as more obese, sedentary teenagers and adolescents develop and diabetes.

Lipitor is approved to lower risk of and stroke, but can cause dangerous or weakness, and it cannot be taken by patients with liver problems or by nursing or pregnant women.

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Birthmark
3.7 / 5 (3) Jul 06, 2010
I know it says "inherited disease" but I still feel there is a correlation between parents eating habits and their kids DNA. DNA CAN change.

KIDS SHOULD NOT NEED THESE!!! When are we going to learn that most of our health issues are caused by our foods that are laced in sugar, salt, fat, pesticides, hormones, and radiation, and lacking vitamins, protein, and fiber?
Sepp
5 / 5 (1) Jul 07, 2010
Definitely a BAD idea to feed a drug to children that wreaks havoc with a great number of metabolic pathways by blocking cholesterol synthesis.

This is based on the idea that cholesterol is bad for you, which is by no means a given.

Disease mongering at its best.
Skeptic_Heretic
1 / 5 (1) Jul 07, 2010
I know it says "inherited disease" but I still feel there is a correlation between parents eating habits and their kids DNA. DNA CAN change.
Actually I agree. Epigenetics is still a rather large grey area but there's a startling amount of observational and statistical evidence supporting it. I'm not sure who downranked your comment or why.
jerryd
not rated yet Jul 13, 2010
I have this inherited problem but Lipitor almost killed me giving me fibromilagia symtoms of extreme weakness and muscle pain.

Cholesterol is an important part of muscles, nerve, brain and other cells. Stopping it from working can be very dangerous and should not be used in children or long term.

When are people going to learn big Pharma will do, say, cheat anything to keep their patented drugs on the market even killing people.

I used diet to fix my problems, just eat less, less fatty, processed foods, more veg, fruits to loose weight and the rest follows.

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