Anemia

Roche submits added data to U.S. FDA to support license application for anti-anemia agent

Published in Health Business Week, January 19th, 2007

Roche announced that it has submitted additional data to the U.S. Food and Drug Administration (FDA) to support its biologic license application (BLA) for Mircera.

These data offered are intended to provide as comprehensive an understanding of Mircera as is possible to assist the FDA in completing the review process. As a result of this action, the FDA has granted Roche a 3-month extension to the review period.

Roche is seeking an indication for Mircera in the treatment of anemia associated with chronic kidney disease (CKD) including patients on dialysis and not on dialysis. The BLA submitted to the FDA is based on data from all six studies that...

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Source: Health Business Week (2007-01-19)

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