Roche announced that the US Food and Drug Administration (FDA) has issued an approvable letter for Mircera for the treatment of anaemia associated with chronic renal failure including patients on dialysis and patients not on dialysis.

Roche has received a draft label for Mircera 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 autumn and it is understood that recommendations from this meeting could impact the entire class labelling for all ESAs.

"Today's announcement is good news for us as it confirms our confidence in Mircera. We expect no further clinical trials being required prior to approval," said William M Burns, CEO of the Pharmaceutical Division at Roche. "We see the upcoming class review as an opportunity to launch Mircera powerfully into a, by then, clarified market. We believe it is much better for Roche to enter the US when physicians and patients have assurance about the proper use of these drugs," he added. Roche will work with the FDA following this meeting in order to expedite the conclusion of the review process.

Mircera is the first of a new class of long-acting chemically synthesized erythropoiesis-stimulating agents (ESAs) developed for the treatment of anaemia in chronic kidney disease (CKD) patients. Mircera has a longer half-life than any commercially available ESA.