Myelodysplastic Syndromes

Vidaza maker withdraws E.U. marketing authorization application

Published in Blood Weekly, December 15th, 2005

Pharmion Corporation (PHRM) confirmed that the European regulatory authorities will require additional data in order to gain marketing approval for Vidaza (azacitidine for injectable suspension) in Europe and announced the withdrawal of its marketing authorization application (MAA).

Pharmion intends to incorporate data from the company's ongoing survival trial into the MAA.

Pharmion is currently sponsoring a study of 354 high-risk myelodysplastic syndromes (MDS) patients comparing Vidaza to best supportive care (BSC) with or without low-dose chemotherapy, with overall survival as the primary endpoint of the study. Secondary endpoints in the trial...

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Source: Blood Weekly (2005-12-15)

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