The European regulatory authorities have approved a chewable formulation of Pfizer’s Lipitor for the treatment of familial hypercholesterolemia in children aged 10-17 years. The pediatric indication has also been sanctioned for the currently available tablet form of Lipitor. Approval of the drug for this younger patient population is based on data from a pediatric investigation plan Pfizer filed with the European Medicines Agency in November 2009.
The firm says the EU has created a number of incentives to help persuade companies to invest in clinical development of drugs for use in children. These incentives include the potential to prolong patent life by another six months by applying for an extension to an existing supplementary protection certificate (SPC). Pfizer confirmed it plans to apply for the six-month patent extension in European countries where it has an SPC.
Lipitor has been approved in the U.S. for treating heterozygous familial hypercholesterolemia in children aged 10-17 years since 2002.