Celgene's Vidaza approved in Europe

US drugmaker Celgene's Vidaza (azacitidine) has been granted full marketing authorization by the European Commission for the treatment of  adult patients who are not eligible for hematopoietic stem cell  transplantation with: intermediate-2 and high-risk myelodysplastic  syndrome; chronic myelomonocytic leukemia with 10%-29% marrow blasts  without myeloproliferative disorder; or acute myeloid leukemia with  20%-30% blasts and multi-lineage dysplasia.

Philippe Van Holle, president of Celgene Europe, said: "we will now  begin working with local regulatory authorities on a country-by-country  basis for reimbursement and distribution for all European Union member  states."

The approval was based upon efficacy and safety data from clinical  studies evaluating Vidaza in MDS and RAEB-T patients within the AML  category as defined by the World Health Organization classification  system. These pivotal efficacy and safety data were primarily provided  from the Vidaza survival trial (AZA-001), the largest, international  randomized Phase III controlled study ever conducted in higher-risk MDS  and WHO AML patients, demonstrating a clinically-relevant increase in  median survival of 9.4 months (24.4 versus 15 months) compared to  conventional care regimens.