GlaxoSmithKline submits new drug application for daprodustat for renal anemia to Japan's Ministry of Health, Labour and Welfare

recently, GlaxoSmithKline (GSK) submitted to the Ministry of Health, Labour and Welfare (MHLW) aapplication for a new drug(http://(NDA) to approve oral hypoxic-inducing factor protalysinase inhibitor (HIF-PHI) daprodustat for the treatment of renal anemia caused by chronic kidney disease (CKD)Daprodustat NDA is based primarily on positive data on Phase III projects carried out in JapanThese studies assessed the efficacy of daprodustat treatment for anemia in patients with chronic kidney disease stage III-V, including those who received dialysis and those who did not receive dialysis, regardless of whether they had previously received red blood cell production stimulator (ESA) for anemiaLast November, GlaxoSmithKline (GSK) signed a strategic cooperation agreement with Japan's pharmaceutical company Concord fermentation Kirin for the future commercialization of the Japanese marketUnder the terms of the agreement, GlaxoSmithKline (GSK) will be responsible for completing phase III clinical projects and regulatory submissions authorized in the Japanese marketAfter obtaining regulatory approval, Concord Fermentation Kirin will be spending sole time for daprodustat distribution in the Japanese marketGlaxoSmithKline (GSK) is conducting a Phase III global registration project that includes two Phase III studies to evaluate daprodustat for dialysis patients with CKD-dependent anemia (ASCEND-D study) and dialysis for patients with non-dependence on CKD anemia (ASCEND-ND), the results of which are expected to be available by 2020