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Ceplene rebuffed by EU regulator


Drug firm EpiCept has been dealt a blow in its efforts to get a marketing authorisation application (MAA) for Ceplene (histamine dihydrochloride), which is intended for patients with acute myeloid leukaemia (AML) in first remission.

Members of the European Committee for Medicinal Products for Human Use (CHMP) received an update on the application, but felt further clinical data was required.

Jack Talley, president and CEO of EpiCept, said: “We are disappointed with the results of this non-binding trend vote by the CHMP, which we believe are inconsistent with the strength of the data we submitted on Ceplene for AML.

“We are particularly disappointed that AML patients, for whom this treatment is intended, may be denied the opportunity to extend their disease-free survival as currently no approved treatment is available which will maintain remission in these patients.

“We believe our application for this Orphan Drug adequately demonstrated the benefits of Ceplene in prolonging leukaemia-free survival when used in conjunction with low-dose interleukin-2 (IL-2).

“The MAA is supported by data sufficient for approval under the regulations, specifically, approval based on a single pivotal trial where the drug if approved would satisfy a significant unmet medical need.

“As we head towards a final vote on the MAA next month, we are assessing potential options to gain approval and, if the final opinion is negative, whether that decision should be appealed.”

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