US FDA delays Eisai's Dacogen for AML; accepts perampanel NDA

The US Food and Drug Administration has issued a Complete Response Letter to Japanese drug major Eisai (TYO: 4523) for the supplemental New Drug Application (sNDA) for Dacogen (decitabine) for Injection for patients with acute myeloid leukemia (AML) in adults aged 65 years or older who are not considered candidates for induction therapy. The drug is partnered with US developer Astex Pharmaceuticals (Nasdaq: ASTX).

Following a negative vote by the agency’s Oncologic Drugs Advisory Committee (ODAC) last month (The Pharma Letter February 13), the FDA declined to approve the application because the pre-specified analysis of the primary endpoint in the study (DACO-016) did not demonstrate statistically significant superiority of Dacogen over the control arm (p=0.11), said Eisai.

A separate Marketing Authorization Application for Dacogen was submitted to the European Medicines Agency in May 2011 by Janssen in the treatment of patients with AML. It is expected the EMA will issue a decision on this application later this year.