DacogenTreatment for Myelodysplastic Disease
Approvable Letter Received from the FDA for Dacogen (Decitabine) Injection for the Treatment of MDS.MINNEAPOLIS & DUBLIN, Calif.-- Sep 1, 2005 - MGI PHARMA, INC. (Nasdaq:MOGN) and SuperGen, Inc. (Nasdaq:SUPG) today announced they have received an approvable letter from the U.S. Food and Drug Administration (FDA) for Dacogen(TM) (decitabine) injection for the treatment of myelodysplastic syndromes (MDS). The letter provides 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.
"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 approvable letter from the FDA brings Dacogen injection one step closer to patients suffering from MDS," stated Jim Manuso, president and CEO of SuperGen. "I am confident that MGI PHARMA and SuperGen can promptly provide the information that the FDA has requested."
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 Injection
Dacogen injection belongs to a class of drugs called hypomethylating agents and is the subject of more than 40 ongoing clinical trials. In clinical trials, Dacogen injection has demonstrated activity in several hematological malignancies as well as solid tumors. 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. The New Drug Application (NDA) and Marketing Authorization Application (MAA) for Dacogen injection for MDS are currently under review by the United States Food and Drug Administration (FDA) and European Medicines Agency (EMEA), respectively.
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Posted: September 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
- MGI PHARMA and SuperGen Provide Regulatory Status Updates for Dacogen (decitabine) Injection for MDS - November 15, 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