Pharmaprojects R&D Pipeline News Feed
Long-awaited approval for EpiCept’s acute myeloid leukaemia therapy
9 October 2008
Tarrytown, New York headquartered company EpiCept has received European Commission approval for its acute myeloid leukaemia (AML) therapy histamine dihydrochloride (Ceplene). This first approval in all 27 member states of the EU, Iceland, Liechtenstein and Norway gives adult AML patients in first remission an additional treatment option for the maintenance of remission and prevention of relapse.
There are numerous therapies approved for AML – the most common form of acute leukaemia in adults – which act by via conventional anticancer mechanisms such as alkylating agents and DNA enzyme inhibitors. Ceplene expands the therapeutic approach for a disease that affects nearly 50,000 patients in the EU by offering the novel activity of histamine H2 receptor agonism. It is also reported to be the first therapy available for the prevention of relapse that commonly occurs within 1 to 2 years in AML patients who achieve complete remission.
EpiCept announced the approval exactly 2 years after it submitted the Market Authorization Application to the EMEA on October 9th 2006. The journey to Ceplene’s approval was impeded by a negative opinion in the first quarter of this year that requested additional data. Following EpiCept’s request for a re-examination of the data in May, a positive opinion under the provision of Exceptional Circumstances was granted in 2 months later.
Ceplene was acquired by EpiCept in early 2006 via its merger with San Diego-based Maxim Pharmaceuticals. At the time of the transaction, Maxim had completed a Phase III trial for the remission maintenance in AML patients. Other compounds undergoing late-stage development for AML include Novartis’ staurosporin derivative midostaurin, and Vion Pharmaceuticals’ laromustine for elderly patients with de novo poor-risk AML.
