Kirin's ESA Approved in Japan

Kirin Brewery has been granted Japanese manufacturing and marketing approval for its darbepoetin alfa product, a long-acting erythropoiesis-stimulating agent (ESA), under the name NESP injection.

NESP, indicated for treating kidney disease patients on dialysis with anemia, was developed under a collaboration with Amgen that began in 1996. Amgen markets the drug as Aranesp in the U.S., Canada, Europe and elsewhere. In Japan, Kirin conducted clinical studies of NESP in 2,000 hemodialysis patients and filed an application for approval in 2005.

More than 250,000 patients are undergoing dialysis treatment in Japan, according to Kirin. Renal anemia is the main complication in these patients, roughly 80 percent of which are treated with recombinant human erythropoietin alpha preparations. Kirin first began marketing one of these products in 1990 and expects its new drug to provide additional benefits, including reduced frequency of administration.

Additional clinical studies of NESP are under way in patients with chronic kidney disease who are not on dialysis and in cancer patients with chemotherapy-induced anemia, the company said.