Based on the results of Pfizer-sponsored trials, in March, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended that a pediatric-appropriate formulation of Lipitor (chewable tablets) be approved for the treatment of hypercholesterolaemia 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). The European Commission Decision formalizes these recommendations, which must now be implemented in all EU member states.
As a result of an earlier pediatric clinical development program, Lipitor has been approved for use in children (aged 10 to 17 years) with heterozygous familial hypercholesterolemia in the United States since 2002.
SOURCE Pfizer Inc.