EPICEPT FILES FOR APPROVAL OF LEUKEMIA DRUG IN EUROPE
EpiCept announced it has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMEA) for Ceplene (histamine dihydrochloride), the company's lead oncology product candidate, administered in conjunction with interleukin-2 (IL-2), for the maintenance of first remission in patients with acute myeloid leukemia (AML).
The MAA submission for Ceplene will be reviewed under the EU centralized procedure, and if approved would provide a marketing authorization valid in all EU member states. The European Commission has previously granted orphan drug status to Ceplene for use in the treatment of AML.
The pivotal efficacy and safety data for this MAA submission is from a Phase III clinical trial for Ceplene in conjunction with interleukin-2. This study met its primary endpoint of preventing relapse as shown by increased leukemia-free survival for AML patients in remission. The study was conducted in 11 countries and included 320 randomized patients. The data demonstrated that patients with AML in complete remission who received 18 months of treatment with Ceplene plus low-dose interleukin-2 experienced a significantly improved leukemia-free survival compared with the current standard of care, which is no treatment after successful induction of remission.
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