Pfizer Inc. has received European Commission approval of a new chewable form of Lipitor (atorvastatin calcium) suitable for use in children aged 10 or older with high levels of LDL (“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 (EMA) in November 2009. Investigations into pediatric use are required by recent European pediatric regulations(1) in an effort to encourage pharmaceutical companies to increase understanding of the use of medicines in children. Pfizer hopes to improve treatment options for such pediatric patients, reflecting its ongoing support for patients at risk of cardiovascular disease.
To support the investments necessary to conduct clinical trials in children, the EU created certain incentives, including the availability of a six-month extension to an existing patent extension, also known as a supplementary protection certificate (SPC). As previously announced in November 2009, Pfizer intends to apply for the additional six months of patent protection in European countries where it has an SPC. A country-by-country process will be required to secure this patent term extension.
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.
