EpiCept receives permission to file leukemia drug NDA

EpiCept, a specialty pharmaceutical company, has announced that the FDA indicated that the company has the necessary pivotal data to file a new drug application for Ceplene in conjunction with interleukin-2 as a remission maintenance treatment of acute myeloid leukemia.

Recently, 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 (MAA), which was approved in Europe in October 2008.

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 interleukin-2 (IL-2) and data showing the lack of significant efficacy of IL-2 as a monotherapy for remission maintenance of acute myeloid leukemia (AML).

EpiCept has previously received permission from Health Canada to proceed with a new drug submission (NDS) filing for Ceplene for the treatment of AML. The NDS filing is expected to occur prior to the NDA filing. Decisions by regulators on both applications are expected in 2010.

Jack Talley, president and CEO of EpiCept, said: This is an important advance of our commercial strategy. Ceplene is the first and only approved immunotherapy shown to significantly prolong leukemia-free survival and prevent relapse among AML patients in first remission. We continue to make progress with our partner selection process for Ceplene in Europe, where the drug has full marketing approval, and we will continue to diligently pursue regulatory approval for this important therapy in North America.