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EU approves new form of Pfizer's Lipitor

Pfizer has announced the European Union has approved a new form of the company's cholesterol drug, Lipitor, for use in children

Pfizer has announced the European Union (EU) has approved a new form of the company's cholesterol drug, Lipitor (atorvastatin calcium), for use in patients aged 10 to 17.

The drug is now able to be taken in a chewable form for patients with familial hypercholesterolemia, an inherited disorder which can lead to high levels of low-density lipoprotein (LDL) cholesterol and high triglycerides. These conditions can increase the risk of heart attack and premature death.

The existing tablet form of Lipitor has also been approved for the paediatric age range.

The approval follows a paediatric investigation plan (PIP) filed by Pfizer with the European Medicines Agency (EMA) in November 2009.  Further investigation is required by the EU for medicines to be approved for use in children under European paediatric regulations.

These regulations aim to facilitate the development and availability of medicines for children aged 0 to 17 years; to ensure that medicines for use in children are of high quality; and improve the availability of information on the use of medicines for children.

The Pfizer sponsored PIP involved further trials for both chewable and tablet forms of Lipitor. Based on the results of this research, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended that both formulations of the drug be approved for adolescents and children aged 10 years or older.

Under EU regulation, drugmakers who participate in these extra paediatric trials can apply for a six-month extension to an existing patent extension. This is known as a supplementary protection certificate (SPC).

Pfizer has said it intends to apply for this extra patent protection in European countries.

6th July 2010

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