Pfizer Inc (NYSE:PFE) announced it has submitted pediatric data for Lipitor® (atorvastatin) to the European Medicines Agency (EMEA). Pfizer has also developed a new chewable form of Lipitor, including a pediatric-appropriate 5 mg dose, which is part of this submission.
Approximately one in 500 people suffer from an inherited disorder, called Familial Hypercholesterolemia (FH), which causes high levels of LDL-cholesterol (“bad” cholesterol) and an increased risk of heart disease. Pfizer hopes that additional scientific data about the use of atorvastatin in children with FH will help improve diagnosis and treatment of the condition.
Pfizer’s data submission reflects a European Union (EU) initiative encouraging research, development and availability of medicines for children. All authorized medicines undergo extensive testing in both laboratories and clinical trials prior to their approval. However, there is often limited information available about pediatric use. One 2005 study found that more than half of all medicines in Europe have not been tested and authorized for use in children.
In 2007, the EU enacted a new Regulation requiring pharmaceutical companies to research their medicines for use by children. The requirements cover new medicines, and existing ones under certain circumstances. In 2008, the EMEA’s Paediatric Committee approved Pfizer’s pediatric investigation plan to study the use of Lipitor in children aged 6 to under 18. This week, the Committee concluded that Pfizer’s pediatric atorvastatin program has been implemented in compliance with its requirements.