The letter states that Dacogen injection is approvable pending the FDA’s review of a requested analysis of the transfusion requirements of patients enrolled in the completed phase III trial, submission of certain other information, and completion of labeling discussions.
“We are working diligently to complete the requested analysis of data and provide this information to the FDA as early as possible during the fourth quarter,” stated Lonnie Moulder, president and CEO of MGI Pharma. “The MGI Pharma commercial organization is prepared to launch Dacogen injection upon final FDA approval.”
The majority of MDS (myelodysplastic syndromes) cases are seen in patients over 60 years of age. The Aplastic Anemia and MDS International Foundation currently estimates that 20,000 to 30,000 new cases of MDS are diagnosed annually in the US.