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news.Ark Therapeutics Group, a healthcare group, has filed the marketing authorization application for Cerepro, the company's novel gene-based therapy for operable malignant glioma, with the European medicines regulatory agency.
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The marketing authorization application (MAA) for Cerepro, filed following a pre-submission meeting with the European medicines regulatory agency (EMEA), will now enter the validation stage, prior to commencing formal review. The MAA for Cerepro will be reviewed via the centralized procedure which is the standard route for all advanced therapies.
Cerepro was originally filed for marketing approval under exceptional circumstances, in late 2005 and was reviewed by the EMEA Committee for Medicinal Products for Human Use with reliance on Phase II data. The review established that the technical chemistry and manufacturing controls, preclinical and environmental sections appeared acceptable, but more clinical data were needed to confirm the Phase II findings and demonstrate the reproducibility of the results in a larger multi-centre trial.
Nigel Parker, CEO of Ark, said: We are very pleased to report this filing in accordance with our plans. Increasingly we see that gene based medicine has the potential to deliver solutions for many diseases that are untreatable today and Ark has become recognized as a world leader in this area of medicine.