GSK submits a application for a new drug for daprodustat to MHLW Japan

recently, GlaxoSmithKline (gsk) submitted a new drug application (nda) to japan's Ministry of Health, Labour and Welfare (mhlw) for approval of oral hypooxygenated factor proline hydroxygen inhibitor (hif-phi) daprodustat to treat renal anemia caused by chronic kidney disease (ckd).daprodustat nda is based on positive data on phase iii projects in Japan.these studies evaluated the efficacy of daprodustat in the treatment of anemia in patients with stage iii-v chronic kidney disease, including patients on dialysis and those who did not receive dialysis, regardless of whether they had previously received red blood cell production stimulants (esa) to treat anemia.Last November, GlaxoSmithKline (gsk) signed a strategic cooperation agreement with the Japanese pharmaceutical company Concord Fermentation Kirin for the future commercialization of daprodustat in the Japanese market.
terms of the agreement, GlaxoSmithKline (gsk) will be responsible for completing phase iii clinical projects and regulatory submissions authorized in the Japanese market. After obtaining regulatory approval, Concorde Fermentation Kirin will be solely responsible for the distribution of daprodustat in the Japanese market.GlaxoSmithKline (gsk) is conducting a global phase iii registration project, which includes two phase iii studies evaluating daprodustat for dialysis-dependent anaemia patients (ascend-d studies) and dialysis non-dependent ckd anemia patients (ascend-nd studies), the results of which are expected to be available in 2020. (Drug Advisory Network)