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Published on 18 May 2009

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Unproven drug approved for malignant glioma

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Named Patient Supply (NPS) for Ark Therapeutics’ drug Cerepro has been approved by Finland’s National Agency for Medicines.

NPS is a provision whereby unlicensed medicines can be used on patients if they have a special need which cannot be fulfilled through traditional prescriptions.

This can arise because: a medicine is awaiting a licence; a licensed medicine is available but is not suitable for the patient; or the product is used to treat a rare disorder, often classified as an orphan drug – a pharmaceutical agent that has been developed specifically to treat a rare medical condition.

The gene-based medicine from Ark is being developed as an orphan drug for the treatment of operable malignant glioma.

The approval follows an application made by a neurosurgeon in Finland for the use of Cerepro. Finland is the second country to approve NPS for the drug after France gave its approval in February 2009.

Dr Nigel Parker, chief executive at Ark, said: “We are very pleased to report this second NPS approval. It is encouraging to see surgeons who have experience of the drug in clinical trials wanting to use the product in normal clinical practice.

“Glioma is a terrible disease with a poor prognosis and as such is an area of medicine where new treatments are much needed.”

Copyright Press Association 2009

National Agency for Medicines



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