MGI Pharma Inc. and SuperGen Inc.provided a regulatory updates for Dacogen (decitabine) injection for the treatment of myelodysplastic syndromes (MDS). The MDS new drug application is currently under review by the US Food and Drug Administration and the marketing authorisation application (MAA) is under review by the European Medicines Agency (EMEA).
MGI Pharma and SuperGen have completed the required collection and analysis of transfusion data in response to the approvable letter received for Dacogen injection on September 1, 2005. Following discussions with the FDA, MGI Pharma and SuperGen will finalise and submit their response to the approvable letter. The companies believe this planned submission confirms the clinical benefit of Dacogen injection compared to supportive care with regard to overall response rate, duration of response and transfusion independence in patients with MDS, states a company release.
The review process for the MAA for Dacogen injection continues to be underway in Europe. Following a meeting with EMEA staff earlier this morning, the Companies believe that the potential outcomes of the MAA review may include a final CHMP opinion or the need to submit additional data to support the application. MGI Pharma and SuperGen will provide an update on the status of the MAA by year-end. MGI Pharma continues to conduct late-stage licensing negotiations with potential partners for rights to Dacogen injection outside of North America, and anticipates that a final decision regarding the European regulatory strategy may be finalized in collaboration with a partner.
Dacogen injection is a product candidate that belongs to a class of drugs called hypomethylating agents and is the subject of a broad, ongoing clinical program. MGI Pharma is currently conducting a pivotal program to evaluate Dacogen injection in patients with acute myeloid leukemia (AML). Additional studies are also underway to evaluate alternative dosing regimens for Dacogen injection. Dacogen injection is not approved for marketing in the US or by any other regulatory agencies in their respective countries.