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news.EpiCept, a specialty pharmaceutical company, has announced that the European Commission has granted a full marketing authorization in the form of a positive commission decision, for Ceplene for the remission maintenance and prevention of relapse in adult patients with acute myeloid leukemia in first remission.
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Ceplene is to be administered in conjunction with low-dose interleukin-2 (IL-2). The approval allows Ceplene to be marketed in the 27 member states of the EU, as well as in Iceland, Liechtenstein and Norway.
The approval by the European Commission is based, in part, on the results of the pivotal 320-patient Phase III trial for Ceplene in conjunction with IL-2.
As a result of its designation as an orphan medical product, EpiCept has been granted 10 years of market exclusivity in the EU for Ceplene. As part of receiving marketing authorization under exceptional circumstances for Ceplene, EpiCept will perform two post-approval clinical studies.
One of the studies will seek to further elucidate the clinical pharmacology of Ceplene by assessing certain biomarkers in acute myeloid leukemia (AML) patients in first remission. The other study will assess the effect of Ceplene/IL-2 on the development of minimal residual disease in the same patient population. EpiCept is considering combining these studies into a single clinical trial.
EpiCept has also advanced its efforts to gain approval for Ceplene as a remission maintenance treatment for AML patients in North America.
Jack Talley, president and CEO of EpiCept, said: “Ceplene is now the first approved therapy demonstrated to produce a clear benefit in prolonging leukemia-free survival and preventing relapse among AML patients. We are proud that this new therapeutic option will be available to physicians and patients in 30 countries.”