FDA approves new treatment for Myelodysplastic Syndromes
The US Food and Drug Administration has approved Dacogen (decitabine) injection for the treatment of myelodysplastic syndromes (MDS). Initially developed by SuperGen, the drug is being commercialised by MGI Pharma of Minneapolis, who said it will be commercially available during the second quarter of 2006.
The US Food and Drug Administration has approved Dacogen (decitabine) injection for the treatment of myelodysplastic syndromes (MDS). Initially developed by SuperGen, the drug is being commercialised by MGI Pharma of Minneapolis, who said it will be commercially available during the second quarter of 2006.
Dacogen is a new molecular entity that received orphan drug status, and is manufactured for MGI by Pharmachemie of Haarlem, in the Netherlands.
Patients with MDS have bone marrow that does not produce enough mature blood cells. This causes a lack of healthy blood cells that can function properly in the body. Dacogen is thought to work by promoting normal development of blood cells.
Different types of MDS exist. It can develop following treatment with drugs or radiation therapy for other diseases or it can develop without any known cause. Some forms of MDS can progress to acute myeloid leukemia (AML), a cancer in which too many white blood cells are made.
An estimated 7,000 to 12,000 new cases of MDS are diagnosed yearly in the US predominantly in people over 60 years of age.