Roche, a global healthcare leader focused on pharmaceuticals and diagnostics, announced that the European Commission has granted marketing approval for use of subcutaneous NeoRecormon (epoetin beta) once every two weeks in patients with renal anaemia undergoing dialysis. This new regimen cuts by half the number of injections and provides the efficacy and safety benefits seen previously with once-weekly administration.
Anaemia correction, as measured by haemoglobin levels, is effectively maintained when patients who are stable on a once weekly regimen of subcutaneous NeoRecormon are switched to once every two weeks administration. Clinical benefits and tolerability of the once every two weeks regimen is in-line with the well-established efficacy and safety profile of NeoRecormon once weekly, which has been gained over 12 years of clinical experience. Moreover, a less frequent dosing regimen is expected to result in significant cost savings, reducing nursing time and may improve patients compliance.
Professor Boleslaw Rutkowski from the Medical University School in Gdansk, Poland and a lead investigator in the European Collaborative Group which carried out the clinical study on which marketing approval is based, commented: “Reducing the frequency of subcutaneous administration of NeoRecormon to a once every two week regimen has a number of known and potential benefits. Importantly, it significantly reduces the number of injections patients need, encourages patient independence and is more convenient for both home and clinic administration.”
“This is excellent news since this new dosing regimen will significantly improve the quality of life for dialysis patients with renal anaemia. Additionally, this approval reconfirms the efficacy and safety benefits of NeoRecormon, Roche's leading anaemia therapy”, said William Burns, Head of Roche Pharma.
Maintaining target haemoglobin levels decreases the risk of hospitalisation in patients with chronic renal disease, and studies also demonstrate that there are concrete benefits in terms of improved cardiac structure and function, as well as decreased co-morbidities and the risk of death. An analysis of a cohort of over 3000 dialysis patients showed a significant reduction of 20 per cent in all-cause mortality in the first year of treatment with NeoRecormon.
President of the British Renal Society, Dr Donal O'Donoghue said “Treatment strategies that make epoetin administration more convenient for patients are welcomed. For many patients the new once every two weeks NeoRecormon regimen will encourage greater adherence with their anaemia therapy which is important in terms of improving day to day quality of life. Moreover, it may contribute to reducing life threatening cardiac complications, which represent a major risk of mortality in dialysis patients.”