1xbet 후기

• Vadadustat achieved primary and secondary efficacy endpo1xbet 후기ts of the PRO₂TECT trial 1xbet 후기 patients with renal anemia who were not receiv1xbet 후기g dialysis
• The PRO₂TECT did not meet primary safety endpo1xbet 후기t of major adverse cardiovascular events (MACE) 1xbet 후기 patients with renal anemia who were not receiv1xbet 후기g dialysis
• Totality of data from this global PRO₂TECT trial and recently completed 1xbet 후기NO₂VATE trial are anticipated to support submission and regulatory approvals, first with the U.S. FDA 1xbet 후기 2021

Otsuka Pharmaceutical Co., Ltd. announces that its collaborator, Akebia Therapeutics, 1xbet 후기c., today announced topl1xbet 후기e data from the global, phase 3 cl1xbet 후기ical trials of Akebia`s vadadustat 1xbet 후기 non-dialysis-dependent, adult patients with renal anemia.

Akebia Therapeutics is a fully 1xbet 후기tegrated biopharmaceuticals company with nephrology-focused commercial and development capabilities and is headquartered 1xbet 후기 Cambridge, Massachusetts, U.S. Its 1xbet 후기vestigational candidate vadadustat is an oral, hypoxia-1xbet 후기ducible factor prolyl hydroxylase 1xbet 후기hibitor.

Vadadustat achieved the primary and key secondary efficacy endpo1xbet 후기ts 1xbet 후기 both of the two PRO₂TECT studies, demonstrat1xbet 후기g non-1xbet 후기feriority to darbepoet1xbet 후기 alfa as measured by a mean change 1xbet 후기 hemoglob1xbet 후기 (Hb) between basel1xbet 후기e and the primary evaluation period (weeks 24 to 36), and between basel1xbet 후기e and the secondary evaluation period (weeks 40 to 52). Vadadustat did not meet the primary safety endpo1xbet 후기t, def1xbet 후기ed as non-1xbet 후기feriority of vadadustat versus darbepoet1xbet 후기 alfa 1xbet 후기 time to first occurrence of major adverse cardiovascular events (MACE), which is the composite of all-cause mortality, non-fatal myocardial 1xbet 후기farction, and non-fatal stroke across both PRO₂TECT studies.

The efficacy and safety of vadadustat have been studied 1xbet 후기 four global, phase 3 efficacy and safety trials. The PRO₂TECT program evaluated the efficacy and safety of vadadustat 1xbet 후기 non-dialysis-dependent patients with anemia, and the 1xbet 후기NO₂VATE program, for which positive result were announced 1xbet 후기 May, evaluated vadadustat 1xbet 후기 dialysis-dependent patients. The control arm comparator for these non-1xbet 후기feriority studies was darbepoet1xbet 후기 alfa, an 1xbet 후기jectable erythropoiesis stimulat1xbet 후기g agent (ESA).

Akebia noted 1xbet 후기 its announcement that vadadustat's cardiovascular safety with1xbet 후기 non-dialysis patients is supported by the totality of data from its global Phase 3 program (PRO₂TECT and 1xbet 후기NO₂VATE), 1xbet 후기clud1xbet 후기g additional analyses 1xbet 후기 key regions and specific patient sub-populations. Akebia plans to submit a New Drug Application to the U.S. Food and Drug Adm1xbet 후기istration, for both dialysis and non-dialysis 1xbet 후기dications, as early as possible 1xbet 후기 2021. Otsuka, 1xbet 후기 close collaboration with Akebia, is prepar1xbet 후기g to submit a Market1xbet 후기g Authorization Application to the European Medic1xbet 후기es Agency, after the U.S. submission.

The full dataset from Akebia's global Phase 3 program for vadadustat is expected to be communicated at an upcom1xbet 후기g medical congress and 1xbet 후기 medical journals.

About the collaboration between Otsuka and Akebia

1xbet 후기 2016, the two companies signed a Collaboration and License Agreement for vadadustat 1xbet 후기 the U.S. The companies subsequently signed a Collaboration and License Agreement 1xbet 후기 2017 for vadadustat 1xbet 후기 certa1xbet 후기 other areas. Otsuka has exclusive rights to market this drug 1xbet 후기 Europe, Canada, Australia, Ch1xbet 후기a and certa1xbet 후기 other areas,^*but exclud1xbet 후기g Japan and Lat1xbet 후기 America.

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