EpiCept Corporation made the announcement that it has adequate pivotal data to file a New Drug Application (NDA) for Ceplene® (histamine dihydrochloride) in conjunction with interleukin-2 (IL-2). The company has received the permission from the U.S. Food and Drug Administration (FDA) and the drug is indicated to use as a remission maintenance treatment of acute myeloid leukemia (AML).

Jack Talley, President and Chief Executive Officer of EpiCept commented, “We are pleased with the outcome of the pre-NDA meeting. We will be turning our immediate attention to assessing the requirements to submit the NDA in the shortest timeframe possible so as to not deny this unique therapy to AML patients. We are targeting filing the NDA in the second half of this year. This is an important advance of our commercial strategy. Ceplene® is the first and only approved immunotherapy shown to significantly prolong LFS 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. Our intent remains steadfast that with the approval of Ceplene® in North America, we will build a fully integrated commercial organization centered around hematology to market Ceplene® and complementary products.”

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