MGI/SuperGen's myelodysplastic syndromes therapy Dacogen (decitabine) is "approvable" at FDA pending submission of additional analysis of transfusion data.

FDA informed the companies of its decision Sept. 1, the drug's user fee date.

The companies said the agency has requested analysis of the transfusion requirements of all patients enrolled in the completed pivotal Phase III trial and "certain other information." Labeling discussions also must be completed.

MGI and SuperGen submitted the Dacogen NDA for the treatment of MDS Nov. 1. In the pivotal trial, Dacogen was associated with a 9% complete response rate and a 17% overall response rate when added to supportive care.

The companies expect to submit the requested data to the agency early in the fourth quarter, MGI CEO Lonnie Moulder said during a same-day conference call.

"The MGI Pharma commercial organization is prepared to launch Dacogen injection upon final FDA approval," the company said.

MGI Pharma announced a $177.5 mil. acquisition of Guilford in July (¹ Also see "MGI Purchase Of Guilford Will Create Two-Product Acute Care Sales Force" - Pink Sheet, 21 July, 2005.). The deal is expected to close early in the fourth quarter.

- Andrew Shelton

MGI/SuperGen’s Dacogen Is “Approvable” Pending Transfusion Data Analysis

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