GSK sub­mits its first ap­pli­ca­tion for dapro­du­s­tat in Japan; Two drug­mak­ers part with $15M to avoid opi­oid tri­al

→ Just as Hal Bar­ron planned, GSK $GSK has sub­mit­ted its first reg­u­la­to­ry ap­pli­ca­tion for its oral hy­pox­ia-in­ducible fac­tor pro­lyl hy­drox­y­lase in­hibitor (HIF-PHI), dapro­du­s­tat, in Japan for pa­tients with re­nal ane­mia due to chron­ic kid­ney dis­ease (CKD). The ap­pli­ca­tion is based on pos­i­tive Phase III da­ta con­duct­ed in Japan on ane­mic pa­tients across the spec­trum of CKD from stages 3-5 — which in­clud­ed pa­tients on and not on dial­y­sis, re­gard­less of pri­or ane­mia treat­ment with ery­thro­poiesis-stim­u­lat­ing agents (ESAs). If ap­proved, dapro­du­s­tat will be ex­clu­sive­ly dis­trib­uted in Japan by Ky­owa Kirin Co.

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