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Celgene Wins FDA Approval to Expand Vidaza Label

August 22, 2008

Celgene has announced that Vidaza has received expanded FDA approval to reflect new overall survival achieved in the AZA-001 survival study of patients with higher-risk myelodysplastic syndromes.

This expanded indication supplements the 2004 FDA authorization of Vidaza as the first therapy approved in the US for the treatment of patients with all five French American British subtypes of myelodysplastic syndromes (MDS), the company said.

Vidaza is also the first and only drug to show a statistically significant and clinically meaningful extension of survival in higher-risk MDS patients, according to Celgene.

The approval is based upon the significant improvement in overall survival achieved in the Vidaza survival trial (AZA-001), the largest, international randomized Phase III controlled study ever conducted in higher-risk MDS, said Celgene.

Mohamad Hussein, global head of medical affairs for hematology at Celgene, said: “Vidaza is another example of Celgene developing novel therapies for critical blood diseases that are enabling patients to live for years, rather than weeks and months. Today’s decision strengthens our company’s ability to deliver Vidaza and our other therapies to patients in need around the world.”




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