Ceplene histamine dihydrochloride regulatory update

EpiCept said FDA refused to file an NDA for Ceplene histamine dihydrochloride for use in combination with low-dose IL-2 to maintain remission and prevent relapse in patients with acute myelogenous leukemia (AML) in first complete remission. According to EpiCept, FDA said the NDA did not demonstrate the compound's "therapeutic contribution" in combination with IL-2 and recommended that the company conduct an additional pivotal trial comparing Ceplene plus IL-2 vs. IL-2 alone using overall survival (OS) as the primary endpoint. EpiCept said based on a prior discussion with the agency, it had submitted data from a meta-analysis comparing Ceplene plus IL-2 vs. IL-2 alone, which showed a significant benefit on the primary endpoint of leukemia-free survival in favor of Ceplene plus IL-2. ...