Ceplene is EpiCept’s lead oncology product candidate that administered in conjunction with low dose interleukin-2 will be indicated for use in the maintenance of first remission in patients with acute myeloid leukemia (AML).
Validation of the application means that the EU has reviewed the application for completeness, selected the reviewers for the application and set a timetable for the review of the product candidate. This positive outcome of validation signifies that the EU centralized evaluation procedure for the marketing authorization application (MAA) will start at the published date of October 25, 2006.
“With the validation of our MAA achieved, we anticipate that we will be able to obtain further insights into the approvability of the compound during the first half of 2007,” remarked Jack Talley, President and CEO.
If the MAA is approved it would provide a marketing authorization valid in all EU member states, together with Iceland, Liechtenstein and Norway. The European Commission has previously granted orphan drug status to Ceplene for use in the treatment of AML.