Kidney dialysis patients can be directly switched from their current anti-anaemia treatment to Roche’s Mircera, according to three Phase III studies reported for the first time yesterday at the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA) meeting in Glasgow, Scotland.
These studies are the first to show that dialysis patients can be switched directly from frequently dosed anti-anaemia treatments to a once-monthly treatment.
Mircera, the first continuous erythropoietin receptor activator (CERA), was filed with regulators in the European Union and the USA in April of this year for the treatment of anaemia associated with chronic kidney disease. Direct switching could make Mircera a very attractive proposition for busy kidney treatment units, since converting a patient to another anti-anaemia treatment usually involves frequently monitoring and increased workload for staff.
The results of these studies are therefore very good news for Roche, especially as Mircera - dosed either every two or four weeks - was as effective as Ortho Biotech’s Procrit, Roche’s own NeoRecormon, and Amgen’s Aranesp dosed between three times a week and once every two weeks.
Roche’s development of Mircera has sparked a bitter patent fight with rival Amgen. The company’s recent decision to delay filing for approval of Mircera in cancer patients was a setback for Roche, though there was also compensation in the US International Trade Commission’s decision to deny Amgen’s challenge and allow continuing import of Mircera into the USA.
The latest results for Mircera will no doubt hot up the Roche-Amgen battle, which will continue until the patent dispute is resolved. The potential anaemia market is well worth the fight, since the condition affects not only kidney patients, but also patients with cancer, diabetes and chronic heart failure.