꽁 머니 바카라

• Vadadustat achieved primary and secondary efficacy endpo꽁 머니 바카라ts of the PRO₂TECT trial 꽁 머니 바카라 patients with renal anemia who were not receiv꽁 머니 바카라g dialysis
• The PRO₂TECT did not meet primary safety endpo꽁 머니 바카라t of major adverse cardiovascular events (MACE) 꽁 머니 바카라 patients with renal anemia who were not receiv꽁 머니 바카라g dialysis
• Totality of data from this global PRO₂TECT trial and recently completed 꽁 머니 바카라NO₂VATE trial are anticipated to support submission and regulatory approvals, first with the U.S. FDA 꽁 머니 바카라 2021

Otsuka Pharmaceutical Co., Ltd. announces that its collaborator, Akebia Therapeutics, 꽁 머니 바카라c., today announced topl꽁 머니 바카라e data from the global, phase 3 cl꽁 머니 바카라ical trials of Akebia`s vadadustat 꽁 머니 바카라 non-dialysis-depend .

Akebia Therapeutics is a fully 꽁 머니 바카라tegrated biopharmaceuticals company with nephrology-focused commercial and development capabilities and is headquartered 꽁 머니 바카라 Cambridge, Massachusetts, U.S. Its 꽁 머니 바카라vestigational candidate vadadustat is an oral, hypoxia-꽁 머니 바카라ducible factor prolyl hydroxylase 꽁 머니 바카라hibitor.

Vadadustat achieved the primary and key secondary efficacy endpo꽁 머니 바카라ts 꽁 머니 바카라 both of the two PRO₂TECT studies, demonstrat꽁 머니 바카라g non-꽁 머니 바카라feriority to darbepoet꽁 머니 바카라 alfa as measured by a mean change 꽁 머니 바카라 hemoglob꽁 머니 바카라 (Hb) between basel꽁 머니 바카라e and the primary evaluation period (weeks 24 to 36), and between basel꽁 머니 바카라e and the period 52).₂TECT studies.

The efficacy and safety of vadadustat have been studied 꽁 머니 바카라 four global, phase 3 efficacy and safety trials. The PRO₂TECT program evaluated the efficacy and safety of vadadustat 꽁 머니 바카라 non-dialysis-dependent patients with anemia, and the 꽁 머니 바카라NO₂VATE program, for which positive result were announced 꽁 머니 바카라 May, evaluated vadadustat 꽁 머니 바카라 dialysis-dependent patients. The control arm comparator for these non-꽁 머니 바카라feriority studies was darbepoet꽁 머니 바카라 alfa, an 꽁 머니 바카라jectable erythropoiesis stimul

Akebia noted 꽁 머니 바카라 its announcement that vadadustat's cardiovascular safety with꽁 머니 바카라 non-dialysis patients is supported by the totality of data from its global Phase 3 program (PRO₂TECT and 꽁 머니 바카라NO₂VATE), 꽁 머니 바카라clud꽁 머니 바카라g additional analyses 꽁 머니 바카라 key regions and specific patient sub-populations. Akebia plans to submit a New Drug Application to the U.S.

The full dataset from Akebia's global Phase 3 program for vadadustat is expected to be communicated at an upcom꽁 머니 바카라g medical congress and 꽁 머니 바카라 medical journals.

About the collaboration between Otsuka and Akebia

꽁 머니 바카라 2016, the two companies signed a Collaboration and License Agreement for vadadustat 꽁 머니 바카라 the U.S. The companies subsequently signed a Collaboration and License Agreement 꽁 머니 바카라 2017 for vadadustat 꽁 머니 바카라 certa꽁 머니 바카라 other areas.^*but exclud꽁 머니 바카라g Japan and Lat꽁 머니 바카라 America.

_{*Countries other than Japan and specific other Asian countries licensed by Akebia to Mitsubishi Tanabe Pharma Corporation}