Pfizer has submitted pediatric data for Lipitor (atorvastatin) to the EMEA. Reportedly, Pfizer has also developed a new chewable form of Lipitor, including a pediatric-appropriate 5mg dose, which is part of this submission.
The company said that, 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.
Reportedly, to encourage companies to make the investments necessary to conduct these trials, the EU also created certain incentives, including the availability of a six-month extension to an existing patent extension, also known as a supplementary protection certificate (SPC).
If Pfizer fulfils all further requirements of the EU paediatric medicines regulation, it will be eligible and intends to apply for an additional six months of patent/SPC protection for Lipitor in certain EU countries.