The new drug application (NDA) for Dacogen (decitabine) injection was submitted to the FDA on November 1, 2004. The acceptance for review of the NDA represents the FDA’s determination that the application is sufficiently complete to permit a substantive review.
The NDA included clinical data from one phase III clinical trial of Dacogen injection in MDS, a cancer of the bone marrow, in addition to two phase II studies.
“This NDA filing represents the achievement of another key regulatory milestone for both MGI Pharma and SuperGen in our quest for marketing approval of Dacogen injection,” said Lonnie Moulder, president and CEO of MGI Pharma.
“We remain committed to bringing this important product to patients as quickly as possible and to exploring the breadth of its clinical potential. We look forward to initiating a phase III study of Dacogen injection in myeloid leukemia (AML) patients in early 2005,” Moulder added.
“We are very pleased that the Dacogen NDA has been accepted for review,” added Dr James Manuso, president and CEO of SuperGen. “We believe that Dacogen injection will become an important treatment option for hematologic cancer patients.”
Under PDUFA (prescription drug user fee act) III, the FDA’s goal is to review and act on the NDA by September 1, 2005.