EU regulator approves Pfizer's Lipitor for children; Cell Thera files pixantrone pediatric investigation plan with EMEA

6 July 2010

The European Commission has approved a new chewable form of global drugs behemoth Pfizer's Lipitor (atorvastatin) suitable for use in children aged 10 or older with high levels of low-density lipoprotein ("bad") cholesterol and high triglycerides due to the inherited disorder familial hypercholesterolemia and other primary causes, which can increase the risk of heart disease and premature death. This pediatric indication has also been approved for the currently available tablet form of Lipitor.

The decision to approve the use of atorvastatin in these pediatric patients in Europe is based on the results of a pediatric investigation plan (PIP) filed by Pfizer with the European Medicines Agency (EMEA) in November 2009. Investigations into pediatric use are required by recent European pediatric regulations in an effort to encourage pharmaceutical companies to increase understanding of the use of medicines in children.

Pfizer will apply for patent extension

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