July 7, 2010
EU Approves Lipitor For Kids
European children with high levels of bad cholesterol and triglycerides will soon have a new way to fight those health issues after the European Union approved a new chewable form of Lipitor, Pfizer said Tuesday.
The approval includes children whose high blood fats are due to inherited disease that causes high cholesterol levels -- familial hypercholesterolemia.
Pfizer Inc won US approval for Lipitor use for children 10 to 17 in 2002.
Lipitor is the world's number-one-selling drug, with $13 billion in revenue in 2009. However, its US patent will expire in November 2011, which the maker, Pfizer, will quickly lose most Lipitor revenue once generic drugs hit the market. So Pfizer is now 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. The European Union allows drug makers to apply for an additional six months of patent protection for medications if they test them in children, who are generally excluded from primary drug studies to win approval for a new drug.
Pfizer had also won a six-month extension in the US after its drug approval in children.
For top-selling drugs, the extensions can easily bring in hundreds of millions of dollars in extra income.
Cholesterol drugs have been mainly used by adults with heart disease and high cholesterol, but as younger patients become more obese and they too potentially develop high cholesterol, heart disease and diabetes, the drugs have become increasingly more popular with them as well.
Lipitor is prescribed to lower the risk of heart attack and stroke, but it can cause dangerous muscle pains and weakness, and it is not for use by people with liver problems or by nursing or pregnant women.
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