Bioenvision Ltd Withdraws Its Application For An Extension Of Indication For Evoltra (clofarabine) - Europe
March 20th, 2008 | by admin |
The European Medicines Agency (EMEA) has been formally notified by Bioenvision Ltd, a whollyowned subsidiary of Genzyme Corporation, of its decision to withdraw its application for an extensionof indication for the centrally authorised medicine Evoltra (clofarabine).
Evoltra was expected to be used for the treatment of acute myeloid leukaemia in elderly patients.Evoltra was first authorised in the European Union on 29 May 2007. It is currently indicated for thetreatment of acute lymphoblastic leukaemia in paediatric patients.
The application for the extension of indication for Evoltra was submitted to the EMEA on 7 February2007. In its official letter, the company stated that the withdrawal of the application was based on theCHMP’s opinion that the data provided did not allow the Committee to conclude that the benefits ofthe medicine outweigh the risks. However, data could be provided in order to support a resubmissionin this indication in the near future.
More information about Evoltra and the state of the scientific assessment at the time of the withdrawalwill be made available in a question-and-answer document. This document, together with thewithdrawal letter from the company, will be published on the EMEA website in due course.
Withdrawal of an application does not prejudice the possibility of a company making a newapplication at a later stage.
European Medicines Agency
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