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news.EpiCept has submitted the documentation to support a re-examination of its marketing authorization application in Europe for Ceplene to the Committee for Medicinal Products for Human Use.
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The comprehensive dossier detailing the grounds for re-examination addresses the three issues that formed the basis of the negative opinion issued by the CHMP on March 19, 2008. The company also submitted in the dossier a signed consensus statement from European acute myeloid leukemia (AML) experts from each of the major European countries acknowledging the critical medical need for a safe and effective remission maintenance therapy for AML patients and that Ceplene when approved would be used in hematology clinical practice for this disease.
Ceplene (histamine dihydrochloride) is intended for the remission maintenance and prevention of relapse in patients with acute myeloid leukemia in first remission. The company anticipates that appeal proceedings in response to this filing will take place in the third quarter of 2008.
Jack Talley, president and CEO of EpiCept, said: “We believe we have completely addressed the concerns of the CHMP and are hopeful that the CHMP appreciates the benefit-to-risk balance of Ceplene and grants a marketing authorization for this important product.”