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EMEA receives paediatric data for Lipitor

Pfizer has submitted new paediatric data for Lipitor to the European Medicines Agency (EMEA)

Pfizer has submitted new paediatric data for its cholesterol treatment Lipitor (atorvastatin) to the European Medicines Agency (EMEA).

The data submission is a response to a 2007 EU regulation that requires pharmaceutical companies to carry out clinical research of drugs intended for use by children. Pfizer's paediatric investigation plan to study the use of Lipitor in children between the ages of six and 18 was approved by the EMEA's paediatric committee in 2008.

The company has developed a chewable form of Lipitor along with a 5mg dose suitable for children.

According to Pfizer, the inherited condition known as Familial Hypercholesterolemia (FH), which causes high levels of LDL-cholesterol and an increased risk of heart disease, affects around one in 500 people.

If Pfizer fulfils all further requirements of the EU Paediatric Medicines Regulation, it will be eligible for, and intends to apply for, an additional six months of patent protection, known as a supplementary protection certificate (SPC), for Lipitor in certain EU countries. This is an incentive created in the EU to encourage companies to make investments and conduct paediatric trials.

18th November 2009

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