22 April 2008 - Ark Therapeutics Group plc today announces that the Paediatric Committee at the European Medicines Agency (EMEA) has given a positive opinion on the Company's Investigation Plan for Cerepro(R) in paediatric patients with high grade glioma. The opinion was adopted by the Committee on 11 April 2008.
As from 26 July 2008, the new European Paediatric Use Regulation requires all new products seeking marketing authorisation in the EU to have an approved plan to ensure they are developed appropriately for the paediatric population.
The plan allows Ark to develop Cerepro(R) for operable high grade glioma in children from 1 month up to 18 years old. The paediatric work will not commence until a European Marketing Authorisation for Cerepro has been granted for the treatment of adults; the Company has been allowed 4 years to complete the work.
Dr Nigel Parker, CEO at Ark commented: 'We continue to be successful in advancing the regulatory process for this breakthrough product. 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. Although paediatric cases of glioma are relatively few, it is clearly important that products such as Cerepro(R) are made available to them.'
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