Roche receives approvable letter for Mircera in the United States

Label to be finalized after FDA’s class review of renal anaemia 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 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.

About Mircera
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.

The filing for Mircera is based on the largest Phase II-III program ever conducted for a drug treating anaemia associated with chronic kidney disease comprising 10 global studies involving more than 2,700 patients from 29 countries. The phase III program consisted of six pivotal studies that explored the use of Mircera to correct anaemia in untreated patients and to maintain haemoglobin after conversion from treatment regimens using existing agents. This program consisted of two correction and four maintenance studies of both intravenous and subcutaneous Mircera given at longer dosing intervals of up to once every four weeks.

Mircera is the only anaemia treatment originally designed to correct anaemia in CKD patients with dosing once every two weeks and maintain CKD patients with dosing intervals up to once a month. It is also the only anaemia therapy to have compared itself in clinical trials against epoetin alfa, beta and darbepoetin alfa.