The product is already available for paediatric use in the US, where the FDA approved it in August for use in children aged three months and older. In Europe the new indication was submitted for approval under the paediatric regulation, which came into effect in January 2007 and is intended to address the shortage of suitably adapted forms of drugs and the lack of information on paediatric dosing.
Companies have generally been reluctant to develop drugs for use in children, mainly because of the costs involved. Instead, doctors have had to estimate the dose or use drugs off label, which has often led to adverse reactions or denied children access to the latest or most effective treatments.
The EU's new regulations in January 2007 intended to address the shortage of suitably adapted drugs for paediatric use. As well as encouraging trials on new paediatric indications of existing drugs like Cancidas, the regulation also targets new active substances. As of July this year, all new drug applications must include the results of trials conducted in children in accordance with a paediatric investigation plan (unless the company applies for a waiver). View full article.