EpiCept ready to file Ceplene NDA

The USA's EpiCept Corp says that the Food and Drug Administration has the necessary pivotal data to file a New Drug Application for Ceplene  (histamine dihydrochloride) in conjunction with interleukin-2 as a  remission maintenance treatment of acute myeloid leukemia.

At a pre-NDA meeting held last week, the FDA provided guidance that it  would accept the clinical data along with other analyses, some of which  had been submitted as part of the Ceplene Marketing Authorization  Application, which was approved in the European Union in October 2008.

At the pre-NDA meeting, the FDA requested that EpiCept provide  additional information to the submission package. The requested  information includes statistical data further supporting the incremental  effectiveness of Ceplene given in conjunction with low-dose IL-2 and  data showing the lack of significant efficacy of IL-2 as a monotherapy  for remission maintenance of AML. The FDA also requested data supporting  leukemia-free survival as an appropriate endpoint in the pivotal Phase  III study for Ceplene, as compared with overall survival. Much of the  requested data already has been generated in connection with the  European MAA filing.