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news.EpiCept Corporation has announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has issued a positive opinion regarding the marketing authorization 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). This positive opinion was issued following a request made by EpiCept to have the initial negative opinion of March 2008 re-examined by the CHMP. Ceplene has been designated as an orphan medicinal product, and as such is entitled to 10 years of marketing exclusivity in the EU.
Following the oral explanation from EpiCept, the CHMP recommended that Ceplene be granted a full marketing authorization under the provision of exceptional circumstances.
As part of granting of the marketing authorization under exceptional circumstances, EpiCept has agreed to perform two post-approval clinical studies. One of the studies seeks to further elucidate the clinical pharmacology of Ceplene by assessing certain biomarkers in 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 entitled to seek further guidance on the design of such studies from the EMEA through the protocol assistance procedure.
The CHMP’s recommendation will now be forwarded to the European Commission for issuing a marketing authorization in the form of a Commission decision, which normally occurs within 67 days. The marketing authorization with unified clinical usage for Ceplene granted under the centralized procedure will be valid for the entire EU as well as in Iceland, Liechtenstein and Norway.