May 27, 2008 - EpiCept Corporation (Nasdaq and OMX Nordic Exchange: EPCT) today announced that it has submitted the documentation to support a re-examination of its Marketing Authorization Application (MAA) in Europe for Ceplene(TM) to the Committee for Medicinal Products for Human Use (CHMP). Ceplene (histamine dihydrochloride) is intended for the remission maintenance and prevention of relapse in patients with Acute Myeloid Leukemia (AML) in first remission. The Company anticipates that appeal proceedings in response to this filing will take place in the third quarter of this year.
During the last few months, EpiCept has received new written support from key opinion leaders in hematology representing numerous European countries, who have unanimously recommended the approval of Ceplene in order to have immediate access to this therapy for their patients. "We have met with many of Europe's leading hematologists and have received overwhelming support for the approval of Ceplene in Europe to address this critical unmet medical need for AML patients," said Stephane Allard, M.D., Chief Medical Officer of EpiCept.
The details can be read here.
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