Chugai withdraws Epogin application

Tokyo-based Chugai, the Japanese subsidiary of Swiss drug major Roche, says it has withdrawn its drug Epogin (recombinant erythropoietin) from Japanese Ministry of Health, Labor and Welfare review, to allow it to conduct an additional clinical trial. Currently, the agent is cleared as a therapy for anemia in patients suffering from end-stage renal disease.

Chugai said the withdrawal decision, which follows extensive discussions with Japan's Pharmaceutical and Medical Devices Agency, will enable it to seek approval for the product as a treatment for chemotherapy-induced anemia. The firm went on to say that the new clinical work would focus on evaluating the drug's risk/benefit profile in the proposed indication, and added that it would resubmit the drug for regulatory assessment in due course.