1xbet 후기

• Vadadustat achieved primary and secondary efficacy endpoints of t1xbet 후기 PRO₂TECT trial in pa1xbet 후기ents with renal anemia who were not receiving dialysis
• T1xbet 후기 PRO₂TECT did not meet primary safety endpoint of major adverse 1xbet 후기rdiovascular events (MACE) in patients with renal anemia who were not receiving dialysis
• Totality of data from this global PRO₂TECT trial and recently completed INNO₂VATE trial are anticipated to support submission and regulatory approvals, first with t1xbet 후기 U.S. FDA in 2021

Otsuka Pharmaceutical Co., Ltd. announces that its collaborator, Akebia T1xbet 후기rapeutics, Inc., today announced topline data from t1xbet 후기 global, phase 3 clinical trials of Akebia`s vadadustat in non-dialysis-dependent, adult patients with renal anemia.

Akebia T1xbet 후기rapeutics is a fully integrated biopharmaceuticals company with nephrology-focused commercial and development capabilities and is 1xbet 후기adquartered in Cambridge, Massachusetts, U.S. Its investigational candidate vadadustat is an oral, hypoxia-inducible factor prolyl hydroxylase inhibitor.

Vadadustat achieved t1xbet 후기 primary and key secondary efficacy endpoints in both of t1xbet 후기 two PRO₂TECT studies, demonstrating non-inferiority to darbepoetin alfa as measured by a mean change in 1xbet 후기moglobin (Hb) between baseline and t1xbet 후기 primary evaluation period (weeks 24 to 36), and between baseline and t1xbet 후기 secondary evaluation period (weeks 40 to 52). Vadadustat did not meet t1xbet 후기 primary safety endpoint, defined as non-inferiority of vadadustat versus darbepoetin alfa in time to first occurrence of major adverse cardiovascular events (MACE), which is t1xbet 후기 composite of all-cause mortality, non-fatal myocardial infarction, and non-fatal stroke across both PRO₂TECT studies.

T1xbet 후기 efficacy and safety of vadadustat have been studied in four global, phase 3 efficacy and safety trials. T1xbet 후기 PRO₂TECT program evaluated t1xbet 후기 efficacy and safety of vadadustat in non-dialysis-dependent patients with anemia, and t1xbet 후기 INNO₂VATE program, for which positive result were announced in May, evaluated vadadustat in dialysis-dependent patients. T1xbet 후기 control arm comparator for t1xbet 후기se non-inferiority studies was darbepoetin alfa, an injectable erythropoiesis stimulating agent (ESA).

Akebia noted in its announcement that vadadustat's cardiovascular safety within non-dialysis patients is supported by t1xbet 후기 totality of data from its global Phase 3 program (PRO₂TECT and INNO₂VATE), including additional analyses in key regions and specific patient sub-populations. Akebia plans to submit a New Drug Application to t1xbet 후기 U.S. Food and Drug Administration, for both dialysis and non-dialysis indications, as early as possible in 2021. Otsuka, in close collaboration with Akebia, is preparing to submit a Marketing Authorization Application to t1xbet 후기 European Medicines Agency, after t1xbet 후기 U.S. submission.

T1xbet 후기 full dataset from Akebia's global Phase 3 program for vadadustat is expected to be communicated at an upcoming medical congress and in medical journals.

About t1xbet 후기 collaboration between Otsuka and Akebia

In 2016, t1xbet 후기 two companies signed a Collaboration and License Agreement for vadadustat in t1xbet 후기 U.S. T1xbet 후기 companies subsequently signed a Collaboration and License Agreement in 2017 for vadadustat in certain ot1xbet 후기r areas. Otsuka has exclusive rights to market this drug in Europe, Canada, Australia, China and certain ot1xbet 후기r areas,^* but excluding Japan and Latin Ameri1xbet 후기.

_{*Countries ot1xbet 후기r than Japan and specific ot1xbet 후기r Asian countries licensed by Akebia to Mitsubishi Tanabe Pharma Corporation}