FDA approves Pharmion's Vidaza
The FDA granted marketing approval to PHRM for its Vidaza azacitidine to treat myelodysplastic syndromes (MDS). The company plans to launch the demethylation agent, which has Orphan Drug status, in "several weeks." PHRM said that Vidaza is the first drug approved to treat MDS.
Also on Wednesday, PHRM pulled its application for European approval of thalidomide to treat multiple myeloma (MM). The company, which earlier this month said EMEA required additional clinical data, plans to resubmit the application. In the third quarter, PHRM plans to complete enrollment in a study of 400 refractory MM patients that is comparing survival of two different thalidomide doses. In the first quarter of 2005, PHRM plans to complete enrollment of 436 newly diagnosed MM patients in a study comparing time to progression and survival for patients receiving thalidomide and dexamethasone versus dexamethasone alone. ...