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Ratiopharm direct has announced the introduction of Eporatio (epoetin theta), a new cost-effective epoetin, following marketing authorisation.
Eporatio is an effective treatment of symptomatic anaemia in pre-dialysis and haemodialysis patients with chronic renal failure.
The new product’s active ingredient, epoetin theta, is a recombinant human erythropoietin, a growth factor regulating the proliferation and differentiation of erythroid progenitor cells.
Eporatio was granted marketing authorisation following a rigorous regulatory process designed to demonstrate quality, safety profile and efficacy.
In nephrology a large scale clinical development programme was undertaken with six clinical phase II/III studies in over one thousand renal anaemia patients.
Multinational, multicentre, randomised, controlled, double-blind, parallel studies in 133 pre-dialysis patients (s.c.) and 150 haemodialysis patients (i.v.) with chronic renal failure showed Eporatio was efficacious when administered to patients not previously treated with an epoetin and demonstrated comparable efficacy to reference product epoetin beta in terms of haemoglobin (Hb) response.
In further studies in 288 pre-dialysis patients (s.c.) and 347 haemodialysis patients (i.v.) Eporatio showed similar efficacy and tolerability to epoetin beta with the mean Hb levels directly comparable during the three month evaluation period. Weekly doses to maintain Hb levels were nearly identical in both groups and dose adaptations were not necessary when patients were switched from maintenance treatment with epoetin beta to EPOratio.
Long-term efficacy of Eporatio in chronic renal failure patients was also evaluated across a nine month period in 289 pre-dialysis patients (s.c.) and 129 haemodialysis patients (i.v.). These studies showed that Eporatio is effective in maintaining the haemoglobin level given once or three times weekly (AUC-Hb 10.73 ± 0.83 g/dL ow, 10.91 ± 0.96 g/dL tiw).
With the launch of the new product in the UK Richard Alexander, Business Unit Director for ratiopharm direct says:
“Eporatio reduces epoetin cost whilst maintaining the epoetin efficacy. After the successful launch of our first product Ratiograstim, last year, this new product once again highlights our ability to deliver a product that combines the dual benefits of high quality and affordable prices.
As you can see the Eporatio Marketing Authorisation is supported by robust clinical data to satisfy the rigorous regulatory process, demonstrating quality, a satisfactory safety profile and efficacy. Clinical trials for Eporatio were conducted in 2,000 patients in total.”
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