MGI Pharma, SuperGen: Dacogen injection under review in U.S., Europe

By E. Janene Geiss

Philadelphia, Oct. 26 - MGI Pharma, Inc. and SuperGen, Inc. announced Wednesday that their new drug application covering the Dacogen injection for treatment of myelodysplastic syndromes is currently under review by the U.S. Food and Drug Administration and the European Medicines Agency.

Company officials said in a news release that they have completed the required collection and analysis of transfusion data in response to the FDA's Approvable Letter, which the companies received Sept. 1.

Following recent discussions with the FDA, the companies said they are planning to finalize and submit their response to the Approvable Letter, officials added.

The companies said they believed 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 myelodysplastic syndromes.

The review process for Dacogen's Marketing Authorization is continuing in Europe, officials said.

Following a meeting with the European Medicines Agency on Wednesday, officials said they believe the potential outcomes of the review may include a final CHMP opinion or the need to submit additional data to support the application.

MGI Pharma officials said they continue to conduct late-stage licensing negotiations with potential partners for rights to Dacogen injection outside of North America.

A final decision regarding the European regulatory strategy may be finalized in collaboration with a partner, MGI officials said.

The companies said they will provide an update on the status of the European review by the end of the year.

Dacogen is a product candidate that belongs to a class of hypomethylating agents.

SuperGen is Dublin-based pharmaceutical company focused on acquisition and development of therapies for solid tumors, hematological malignancies and blood disorders.

MGI Pharma is Bloomington, Minn.-based biopharmaceutical company that acquires, develops and commercializes proprietary products.

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