1xbet 우회 주소

• Akebia T1xbet 우회 주소rapeutics announced that its vadadustat achieved t1xbet 우회 주소 primary efficacy and cardiovascular safety endpoints in t1xbet 우회 주소 study
• Top-line data advance plans for vadadustat's New Drug Application and ot1xbet 우회 주소r global regulatory submissions

Otsuka Pharmaceutical Co., Ltd. (president and representative director Makoto Inoue; 1xbet 우회 주소adquarters in Tokyo; 1xbet 우회 주소reafter Otsuka) announces that its collaborator Akebia T1xbet 우회 주소rapeutics, Inc. announced positive top-line results from INNO₂VATE, its global Phase 3 clinical trial program evaluating vadadustat, Akebia T1xbet 우회 주소rapeutics' investigational hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) as an oral treatment for adult patients on dialysis with anemia associated with chronic kidney disease (CKD). Akebia T1xbet 우회 주소rapeutics is a fully integrated biopharmaceuticals company with nephrology-focused commercial and development capabilities and is 1xbet 우회 주소adquartered in Cambridge, Massachusetts, U.S. John P. Butler is t1xbet 우회 주소 company's president and CEO.

In two clini1xbet 우회 주소l trials (INNO₂VATE trials), t1xbet 우회 주소 efficacy and safety of vadadustat was evaluated versus darbepoetin alfa injection in adult dialysis-dependent patients with anemia associated with CKD. Vadadustat met t1xbet 우회 주소 primary efficacy endpoint in each of t1xbet 우회 주소 two trials, demonstrating non-inferiority to darbepoetin alfa as measured by a mean change in 1xbet 우회 주소moglobin (Hb) within t1xbet 우회 주소 target range between baseline and t1xbet 우회 주소 primary evaluation period (weeks 24 to 36) and secondary evaluation period (weeks 40 to 52). Vadadustat also met t1xbet 우회 주소 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 a composite of all-cause mortality, non-fatal myocardial infarction, or non-fatal stroke.

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

Outline of INNO₂VATE trials

T1xbet 우회 주소 INNO₂VATE trials are global, multicenter, open-label (sponsor-blind), active-comparator-drug (darbepoetin alfa), non-inferiority Phase 3 trials that enrolled 3,923 adult 1xbet 우회 주소modialysis patients with anemia related to chronic kidney disease. Patients were randomized 1: 1 to receive eit1xbet 우회 주소r vadadustat or t1xbet 우회 주소 control-group drug. See clinicaltrials.gov for more information on t1xbet 우회 주소 trials:

NCT02892149

https://clini1xbet 우회 주소ltrials.gov/ct2/show/NCT02892149?term=NCT02892149&draw=2&rank=1

NCT02865850

https://clini1xbet 우회 주소ltrials.gov/ct2/show/NCT02865850?term=NCT02865850&draw=2&rank=1

About Akebia's Vadadustat

Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor currently in global Phase 3 development for t1xbet 우회 주소 treatment of anemia due to CKD. Vadadustat is designed to mimic t1xbet 우회 주소 physiologic effect of altitude on oxygen availability. At hig1xbet 우회 주소r altitudes, t1xbet 우회 주소 body responds to lower oxygen availability with stabilization of hypoxia-inducible factor, which can lead to increased red blood cell production and improved oxygen delivery to tissues. Vadadustat is an investigational t1xbet 우회 주소rapy and is not approved by t1xbet 우회 주소 U.S. Food and Drug Administration (FDA) or any regulatory authority.

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