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EpiCept Corporation today announced that it has submitted the documentation to support a re-examination of its Marketing Authorisation Application (MAA) in Europe for Ceplene to the Committee for Medicinal Products for Human Use (CHMP).
Ceplene (histamine dihydrochloride) is intended for remission maintenance and the prevention of relapse in patients with Acute Myeloid Leukaemia (AML) in first remission. The Company anticipates that appeal proceedings in response to this filing will take place in the third quarter of this year.
During the last few months, EpiCept has received new written support from key opinion leaders in haematology representing numerous European countries, who have unanimously recommended the approval of Ceplene in order to have immediate access to this therapy for their patients.
“We have met with many of Europe’s leading haematologists and have received overwhelming support for the approval of Ceplene in Europe to address this critical unmet medical need for AML patients,” said Stephane Allard, MD, Chief Medical Officer of EpiCept.
The comprehensive dossier detailing the grounds for re-examination addresses the three remaining issues that formed the basis of the negative opinion issued by the CHMP on 19 March 2008. EpiCept believes that this dossier supplies ample and compelling evidence for the approval of the MAA for Ceplene.
The Company also submitted in the dossier a signed consensus statement from leading European AML experts from each of the major European countries acknowledging the critical medical need for a safe and effective remission maintenance therapy for AML patients and that Ceplene, when approved, would be used in haematology clinical practice for this disease.