Chugai Pharmaceutical Co., Ltd. announced the company filed an application with the Japanese Ministry of Health, Labour and Welfare for the approval of an additional indication of chemotherapy-induced anaemia for the recombinant human erythropoietin, "Epogin injection" [generic name: epoetin beta (genetic recombination)].
In the domestic phase III clinical study that plays a central role in this application, patients with chemotherapy-induced anaemia were randomized to receive a weekly dosage of "Epogin Injection" 36,000IU or placebo for 12 weeks to examine efficacy and safety of "Epogin injection" treatment. As a result, the study met its primary endpoint with patients who received "Epogin injection" demonstrating a statistically significant reduction in theoretical transfusion rate compared with those who received placebo. Most common adverse effects observed in patients who received "Epogin injection" included increased blood pressure, hypertension, constipation and diarrhoea.
Patients receiving cancer chemotherapy may experience anaemia resulting from various adverse reactions including bone-marrow suppression. Nonetheless, blood transfusion has been the only treatment option for such anaemia in Japan. Therefore, new treatment options are required.
As the top pharmaceutical company in the field of oncology, Chugai will work for the approval for "Epogin injection" to provide patients and medical practitioners with new treatment options for chemotherapy-induced anaemia as soon as possible.