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news.Pharmion Corporation has submitted a marketing authorization application with the European Medicines Agency for Vidaza in the treatment of patients with higher-risk myelodysplastic syndrome in the European Union.
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Vidaza has been designated as an orphan medicinal product in the European Union (EU) for the treatment of myelodysplastic syndrome (MDS), which, if approved, entitles the drug to 10 years of market exclusivity for the approved indication. The application is based upon clinical data which includes the results from the company’s Phase III multi-center, international, randomized study of Vidaza in the treatment of patients with higher-risk MDS.
Patrick Mahaffy, Pharmion’s president and CEO, said: “We are pleased to submit this application to the European Medicines Agency (EMEA), given the highly compelling data for Vidaza in the treatment of MDS. Vidaza is the only hypomethylating agent, and, in fact, the only drug to have shown an improvement in overall survival in this indication, and we believe it will become the standard of care throughout Europe for higher-risk MDS.”