Roche Receives Approvable Letter for MIRCERA® in the United States

--Label to be finalized after FDA’s class review of renal anemia agents--


Roche announced today that the U.S. Food and Drug Administration (FDA) has issued an approvable letter for MIRCERA® for the treatment of anemia associated with chronic renal failure including patients on dialysis and patients not on dialysis.



Roche has received a draft label from the FDA and expects the label to be finalized after the Cardiovascular and Renal Drugs Advisory Committee (CRDAC)* has issued its recommendations on the entire class of erythropoiesis-stimulating agents (ESAs). As announced earlier, the FDA will convene the meeting to consider class topics related to ESAs in the renal setting. Roche and all other sponsors of ESAs in the United States have been informed of the upcoming CRDAC in the fall, and it is understood that recommendations from this meeting could impact the entire class labeling for all ESAs.



“We are confident that MIRCERA will be approved in the United States,” said George B. Abercrombie, President and Chief Executive Officer, Hoffmann-La Roche Inc., “and we understand and support the FDA’s initiative to convene an advisory panel to review the use of anemia agents in the renal setting. Ultimately, this class review provides the opportunity for Roche to launch MIRCERA into an environment where physicians and patients will have greater clarity on how to use these treatments. Roche will continue to work with the FDA following this meeting in order to expedite the conclusion of the review process.”

Roche believes it is important for there to be competition and choice for U.S. patients, providers and physicians in the management of renal anemia.