Cerepro gets Finnish NPS approval
A named-patient supply for UK-based Ark Therapeutics' Cerepro (sitimagene ceradenovec) for the treatment of operable malignant glioma has been approved in Finland by the National Agency for Medicines.
Finland is the second country to approve an NPS, the first being France in February. NPS is used by clinicians when patients are faced with a terminal diagnosis and allows the use of promising unapproved therapies after existing therapy has failed.
The product has undergone four clinical trials and demonstrated significant efficacy benefits in patients with the condition, according to the firm. A Marketing Authorization Application is currently undergoing formal review at the European Medicines Agency (EMEA).
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