DacogenTreatment for Myelodysplastic Diseases
MGI PHARMA and SuperGen Provide Regulatory Status Updates for Dacogen (decitabine) Injection for MDS
MGI PHARMA and SuperGen have submitted their response to the Approvable Letter received for Dacogen injection to the U.S. Food and Drug Administration (FDA). The Approvable Letter for Dacogen injection, which was received on September 1, 2005, provided 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 3 trial, submission of certain other information, and completion of labeling discussions. The Companies believe that their response addresses all items noted in the Approvable Letter.
The response provided to the FDA by MGI PHARMA and SuperGen confirms that the phase 3 trial of Dacogen injection met its co-primary endpoint of overall response rate (ORR) in patients with myelodysplastic syndromes (MDS). MGI PHARMA and SuperGen intend to provide an update to investors regarding the review timeline for Dacogen injection following receipt of feedback from the FDA.
European Regulatory Strategy Revised
MGI PHARMA and SuperGen have determined that additional clinical data will be required to continue the review of Dacogen injection in Europe. Therefore, the Companies have withdrawn the Marketing Authorization Application for Dacogen injection. This revision in the European regulatory strategy for Dacogen injection does not affect regulatory strategies being pursued in the U.S.
MGI PHARMA and SuperGen will continue to work with European regulatory authorities to determine the information required to support a resubmission of the application, and anticipate resubmitting the application at a later date. MGI PHARMA anticipates that next steps in the European regulatory strategy may be finalized in collaboration with a partner.
Myelodysplastic syndromes, or MDS, are a group of diseases that affects the bone marrow with the majority of cases seen in patients over 60 years of age. Depending on the stage of the disease, the life expectancy for patients diagnosed with MDS is 6 months to 5 years. In MDS, the bone marrow stops making healthy blood cells and instead produces poorly functioning and immature blood cells. People with MDS may experience a variety of symptoms and complications, including anemia, bleeding, infection, fatigue and weakness. Over time, MDS can progress to acute leukemia. The Aplastic Anemia and MDS International Foundation currently estimates that 20,000 to 30,000 new cases of MDS are diagnosed annually in the U.S. Those patients with high-risk MDS may experience bone marrow failure, which may lead to death from bleeding and infection.
About Dacogen (Decitabine) Injection
Dacogen injection is a product candidate that belongs to a class of drugs called hypomethylating agents that is currently being evaluated in a broad clinical development program in patients with MDS, acute myeloid leukemia (AML), chronic myelogenous leukemia, or CML, and solid tumors. Dacogen injection is not approved for marketing in the U.S. or by other regulatory agencies in their respective countries; therefore, safety and efficacy have not yet been established in any patient population. A phase 3 EORTC-sponsored trial is currently ongoing in Europe to evaluate Dacogen injection in patients with MDS. In addition, MGI PHARMA is currently conducting a pivotal program to evaluate Dacogen injection in patients with AML. The New Drug Application (NDA) is currently under review by the FDA in the U.S.
Source: MGI PHARMA
Posted: November 2005
- FDA Approves Five-Day Dosing Regimen for Dacogen (decitabine) for Injection, Offering a New Outpatient Dosing Option for Myelodysplastic Syndromes (MDS) - March 12, 2010
- Dacogen (Decitabine) Injection Complete Response Accepted for Review By U.S. FDA - December 15, 2005
- Approvable Letter Received from the FDA for Dacogen (Decitabine) Injection for the Treatment of MDS. - September 1, 2005
- Dacogen NDA Accepted for Filing by FDA - January 3, 2005
- SuperGen and MGI Pharma Announce Submission of Dacogen NDA to US FDA - November 1, 2004
- SuperGen Submits CMC to FDA as First Component of Rolling New Drug Application for Dacogen - June 1, 2004
- SuperGen Announces FDA Acceptance of Rolling NDA Request for Dacogen - April 22, 2004