SuperGen, MGI predict delay in European OK for Dacogen

SuperGen and collaborator MGI Pharma said that a recent meeting with European regulators has led them to believe that they may have to delay the launch of Dacogen on the continent so they can provide more data on the treatment. The FDA issued an approvable letter for Dacogen September 1, indicating that the drug developers needed to provide more information on the drug before it achieved final marketing approval. SuperGen and MGI Pharma have been seeking regulatory approval to market Dacogen as a treatment for myelodysplastic syndromes, in which the body loses its ability to manufacture healthy new blood cells.

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