A bid by Roche unit Chugai to secure approval for its erythropoiesis-stimulating agent Epogin (epoetin beta) as a treatment of chemotherapy-associated anaemia in cancer patients appear to have suffered a setback.
Chugai says it has withdrawn its marketing application for this indication in Japan so it can carry out additional clinical testing. It is not clear whether the current deliberations over the safety of ESAs in cancer patients have any bearing on the decision, although in a statement the company said the new trial would “be appropriate to evaluate the balance of risks and benefits of Epogin.”
Chugai filed for approval of the chemotherapy indication for Epogin, which is already approved in Japan for the treatment of anaemia associated with kidney disease, towards the end of 2005. The company wants to broaden its uses to counteract a decline in Epogin sales brought about by price cuts in Japan, as well as a reduction in the overall size of the anaemia market due to the introduction of flat-rate reimbursement for epoetin products used in dialysis patients.
The Japanese drugmaker said withdrawing the dossier and supplementing it with additional clinical data would shorten the time to approval.
Epogin, sold as NeoRecormon elsewhere, is still a big earner for Roche, bringing in sales of 2.23 billion Swiss francs ($1.9 billion) last year, slightly down on 2005. The company is trying to expand the franchise via the launch of CERA/Mircera (continuous erythropoietin receptor activator), a longer-acting ESA which has been recommended for approval in the USA and EU. Roche is in the midst of a lengthy patent lawsuit with rival Amgen over this new product.
