New drug - Mircera for anaemia in renal failure

Roche has launched Mircera for the treatment of anaemia associated with chronic kidney disease (CKD).

PHARMACOLOGY
Mircera is a continuous erythropoietin receptor activator and stimulates erythropoiesis by interaction with the erythropoietin receptor on progenitor cells in the bone marrow.

 

CLINICAL STUDIES
The efficacy of Mircera has been assessed in several phase III open-label randomised studies. Two studies1,2 examined the efficacy of Mircera in correcting anaemia in erythropoiesis stimulating agent-naïve patients with CKD.

Mircera was given once fortnightly by IV or subcutaneous administration in patients on dialysis and not on dialysis, respectively. Haemoglobin response rates in the IV and subcutaneous Mircera groups were 93.3 per cent and 97.5 per cent, respectively.

A third study3 examined the efficacy of Mircera administered subcutaneously up to once monthly, in patients with CKD on dialysis previously maintained on epoetin a or b one to three times weekly. Once-monthly and twice-monthly Mircera was shown to be as effective as epoetin in patients converted directly from epoetin therapy.

 

1. Klinger M, Arias M, Vargemezis V et al. CERA (continuous erythropoietin receptor activator) administrated at extended intervals corrects Hb levels in patients with CKD on dialysis. Poster presented at The American Society of Nephrology 39th annual meeting November 14-19 2006.
2. Macdougall I, Walker R, Provenzano R et al. CERA (continuous erythropoietin receptor activator) administrated at extended intervals corrects anaemia and maintains stable Hb levels in patients with CKD not on dialysis. Poster presented at The American Society of Nephrology 39th annual meeting November 14-19 2006.
3. Sulowicz W, Locatelli F, Ryckelynck J et al. Once-monthly subcutaneous CERA maintains stable haemoglobin control in patients with chronic kidney disease on dialysis and converted directly from epoetin one to three times weekly. Clin J Am Soc Nephrol 2007: 2; 637-46.

 

Further information: Roche 01707 366000


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