Ratiopharm direct has announced the introduction of Eporatio (epoetin theta), a new cost-effective epoetin, following marketing authorisation.
Eporatio is shown to be effective in treating symptomatic anaemia in cancer patients with non-myeloid malignancies receiving chemotherapy.
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 oncology a large scale clinical development programme was undertaken with three clinical phase III studies in 586 cancer anaemia patients.
A multinational, multicentre, randomised, placebo-controlled, active-controlled, double-blind, parallel-group compared Eporatio to reference product epoetin beta amongst 149 patients with solid tumours, receiving platinum-containing chemotherapy and having a haemoglobin level ≤ 11 g/dL1. 1
Eporatio demonstrated a comparable efficacy and safety profile to epoetin beta and superior efficacy to placebo in terms of complete haemoglobin response. The mean dose at time of complete response was 30,000 IU for Eporatio and 42,231 IU for epoetin beta so comparable efficacy results were achieved at a lower dosage for Eporatio.
A further placebo-controlled study looked at 186 patients with solid tumours or non-myeloid haematological malignancies receiving non platinum chemotherapy and having a haemoglobin level of ≤ 11 g/dL.
The mean dose at time of complete response was 27,681 IU for Eporatio once again demonstrating the efficacy and tolerability of the new product at a lower dosage with 66.7% of the responders showing a complete haemoglobin response with the initial dose of 20,000 IU/week.
The efficacy and safety profile of Eporatio was further highlighted amongst 177 anaemic cancer patients with low grade non-Hodgkin’s lymphoma, chronic lymphocytic leukaemia or multiple myeloma receiving anticancer therapy and having a haemoglobin level of ≤ 11 g/dL.
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. Indeed clinical trials for Eporatio were conducted in over 2,000 patients in total.”
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