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news.EpiCept, a specialty pharmaceutical company, has received permission to proceed with a new drug submission filing for Ceplene for the treatment of acute myeloid leukemia in Canada.
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Based on input received at the pre-new drug submission (NDS) meeting, the company believes that no additional pivotal clinical data beyond that which was submitted as part of the marketing authorization application filed for Ceplene in Europe will be required for this NDS filing.
Previously, Ceplene received full marketing approval in the EU for maintenance therapy and prevention of relapse in adult patients with acute myeloid leukemia (AML) in first remission. EpiCept is currently in the process of selecting a European commercial partner for this new therapy.
Jack Talley, president and CEO of EpiCept, said: We are pleased with the outcome of our pre-NDS meeting with officials from Health Canada and look forward to advancing Ceplene in this key market. As part of our North American regulatory strategy for Ceplene, we also expect to participate in a pre-new drug application meeting with the FDA in the first quarter of 2009.
Ceplene is the first approved immunotherapy demonstrated to prolong leukemia-free survival and prevent relapse among AML patients in first remission and we remain committed to pursuing approval for this important medicine in North America and other strategic global markets.