Pfizer has received European Union approval for a new chewable form of Lipitor (atorvastatin calcium) suitable for use in children aged 10 or older with high levels of LDL cholesterol and high triglycerides due to the inherited disorder familial hypercholesterolemia and other primary causes.
This pediatric indication also has been approved for the currently available tablet form of Lipitor, according to the New York City-based company.
The decision to approve the use of atorvastatin in these pediatric patients in Europe is based on the results of a pediatric investigation plan filed by Pfizer with the European Medicines Agency (EMA) in November 2009, Pfizer said.
In March, the EMA's Committee for Medicinal Products for Human Use recommended that a pediatric-appropriate formulation of Lipitor (chewable tablets) be approved for the treatment of hypercholesterolemia in adolescents and children aged 10 years or older, and the approval of this indication for the currently available presentations of Lipitor (film-coated tablets).
As a result of earlier pediatric clinical development program, Lipitor has been approved for use in children (aged 10 to 17 years) with heterozygous familial hypercholesterolemia in the U.S. since 2002.