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news.EpiCept has filed a new drug application (NDA) to the FDA for Ceplene (histamine dihydrochloride), administered concomitantly with low-dose interleukin-2 (IL-2) for the remission maintenance and prevention of relapse in patients with acute myeloid leukemia (AML) in first complete remission.
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EpiCept said that Ceplene had received approval for this indication by the European Commission in October 2008 and is currently made available in the UK, Germany and Austria. Ceplene is expected to be available throughout most of the EU within 12 months.
Further, EpiCept has requested priority review of the NDA in its application. The priority review is expected to result in an FDA decision date in late December 2010, following the grant of the request.
Ceplene has been granted orphan drug status in the US, providing seven years’ marketing exclusivity from the NDA approval date.
Ceplene’s NDA submission is supported by a body of evidence demonstrating a clinical benefit of Ceplene/IL-2 for remission maintenance in AML as compared with the standard-of-care, which is no treatment.
The pivotal Phase III study demonstrated that patients with AML in complete remission who received up to 18 months of treatment with Ceplene plus low-dose IL-2 experienced a longer period of leukemia-free survival (LFS) compared to the standard-of-care. The difference between the treated and control group was significant.
At the request of the FDA, EpiCept has included the results of two meta-analyses in its NDA to help isolate Ceplene’s efficacy, which confirmed the lack of clinical efficacy of IL-2 monotherapy as remission maintenance for AML patients and the second demonstrated the contribution of Ceplene in this indication when given in conjunction with IL-2.
Ceplene said that if priority review is not granted, the FDA has up to 60 days to accept the filing for review and assign an FDA decision date.
Additionally, the NDA filing in the US for Ceplene is currently under active review by Health Canada, which is expected to complete its review and provide a decision by the fourth quarter of 2010. Ceplene is also under review by the Israeli Ministry of Health.
Jack Talley, president and CEO of EpiCept, said: “This filing is very important in our strategy for Ceplene, and we are delighted to submit the NDA. We believe that Ceplene, if approved, would favorably impact the prognosis of patients with this disease.”