The plan allows Ark to develop Cerepro for operable high grade glioma in children from one month up to 18 years old. The paediatric work will not commence until a European marketing authorization for Cerepro has been granted for the treatment of adults. The company has been allowed four years to complete the work.
As from 26 July 2008, the new European Paediatric Use Regulation requires all new products seeking marketing authorization in the EU to have an approved plan to ensure they are developed appropriately for the paediatric population.
Nigel Parker, CEO at Ark, said: “Acceptance of the paediatric investigation plan is now an essential part of the centralised regulatory approval process in Europe and we are very pleased to have successfully achieved this step.”