Celgene Corp.

U.S. FDA grants Revlimid NDA approval

Published in Genetics and Environmental Business Week, January 26th, 2006

Celgene Corp. (CELG) announced that the U.S. Food & Drug Administration (FDA) granted approval of Revlimid (lenalidomide), which is indicated for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.

Revlimid will be available through a Revlimid education and prescribing safety program, called RevAssist, via contracted pharmacies.

"The clinical data from a phase II trial of 148 patients demonstrated that Revlimid can reduce or even eliminate the need for transfusions in...

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Source: Genetics and Environmental Business Week (2006-01-26)

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