FDA approvable letter delays Mircera launch in US

The FDA has issued Swiss pharmaceutical company, Roche, with an approvable letter for its continuous erythropoietin receptor activator, Mircera, which has further delayed its US market release.

Mircera was filed for use in the treatment of anaemia associated with chronic renal failure. Roche received a draft label from the FDA and said it expected the label to be finalised after the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) issues its recommendations on the entire class of erythropoiesis-stimulating agents (ESAs) in Q3 2007. 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 US were notified of the upcoming CRDAC, and that recommendations from this meeting could impact the entire class labelling for all ESAs.

The Mircera filing was based on the largest initial registration programme conducted in the renal anaemia arena. It consisted of 10 global studies involving more than 2,700 patients from 29 countries. The phase III programme consisted of two correction and four maintenance studies exploring intravenous (IV) and subcutaneous (SC) Mircera at extended administration intervals for patients on dialysis and not on dialysis.

The approvable letter provides breathing space to US-based competitor company Amgen, whose best-selling anaemia drugs are Epogen and Aranesp. Epogen, which is sold for dialysis use in the US, racked up sales of USD 2.5bn in FY06. Medicare, which pays for most dialysis treatments, spends more than USD 2bn a year on the drug.

Had Mircera won market approval, Amgen's overall monopoly on anaemia drugs for patients undergoing kidney dialysis would have ended. The US company also receives royalties from Johnson & Johnson's sales of its other anaemia drug, Procrit, which is not allowed be used for dialysis patients under the terms of the agreement between the two firms.

Amgen's shares rose USD 0.71 to USD 54.75 after ending the regular trading session up USD 0.36 to USD 54.04 on 19 May.

The FDA's caution is due to several studies published over the last six months, which have suggested that anaemia drugs can cause heart problems, blood clots and make cancer spread faster in patients undergoing chemotherapy.

Roche expects Mircera to be approved after the autumn meeting of the CRDAC, as its application is solely for kidney failure, although the company says it should win approval for cancer patients also.

George B Abercrombie, the CEO of Roche's US operations, said: "We are confident that Mircera will be approved in the US, and we understand and support the FDA's initiative to convene an advisory panel to review the use of anaemia agents in the renal setting."

Amgen is currently involved in a patent infringement lawsuit against Roche in a separate attempt to keep Mircera off the US market. The trial is set to begin in September 2007 in federal court in Boston, with a ruling possible before the FDA approves Mircera. Amgen's patents for its anaemia drugs expired at the end of 2004, but the company succeeded in having six more manufacturing and formulation patents extended to 2015 at the latest.