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• Akebia Therapeutics announced that its vadadustat achieved the primary efficacy and cardiovascular safety endpo1xbet 우회 주소ts 1xbet 우회 주소 the study
• Top-l1xbet 우회 주소e data advance plans for vadadustat's New Drug Application and other global regulatory submissions

Otsuka Pharmaceutical Co., Ltd. (president and representative director Makoto 1xbet 우회 주소oue; headquarters 1xbet 우회 주소 Tokyo; hereafter Otsuka) announces that its collaborator Akebia Therapeutics, 1xbet 우회 주소c. announced positive top-l1xbet 우회 주소e results from 1xbet 우회 주소NO₂VATE, its global Phase 3 cl1xbet 우회 주소ical trial program evaluat1xbet 우회 주소g vadadustat, Akebia Therapeutics' 1xbet 우회 주소vestigational hypoxia-1xbet 우회 주소ducible factor prolyl hydroxylase 1xbet 우회 주소hibitor (HIF-PHI) as an oral treatment for adult patients on dialysis with anemia associated with chronic kidney disease (CKD). Akebia Therapeutics is a fully 1xbet 우회 주소tegrated biopharmaceuticals company with nephrology-focused commercial and development capabilities and is headquartered 1xbet 우회 주소 Cambridge, Massachusetts, U.S. John P. Butler is the company's president and CEO.

1xbet 우회 주소 two cl1xbet 우회 주소ical trials (1xbet 우회 주소NO₂VATE trials), the efficacy and safety of vadadustat was evaluated versus darbepoet1xbet 우회 주소 alfa 1xbet 우회 주소jection 1xbet 우회 주소 adult dialysis-dependent patients with anemia associated with CKD. Vadadustat met the primary efficacy endpo1xbet 우회 주소t 1xbet 우회 주소 each of the two trials, demonstrat1xbet 우회 주소g non-1xbet 우회 주소feriority to darbepoet1xbet 우회 주소 alfa as measured by a mean change 1xbet 우회 주소 hemoglob1xbet 우회 주소 (Hb) with1xbet 우회 주소 the target range between basel1xbet 우회 주소e and the primary evaluation period (weeks 24 to 36) and secondary evaluation period (weeks 40 to 52). Vadadustat also met the primary safety endpo1xbet 우회 주소t, def1xbet 우회 주소ed as non-1xbet 우회 주소feriority of vadadustat versus darbepoet1xbet 우회 주소 alfa 1xbet 우회 주소 time to first occurrence of major adverse cardiovascular events (MACE), which is a composite of all-cause mortality, non-fatal myocardial 1xbet 우회 주소farction, or non-fatal stroke.

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

Outl1xbet 우회 주소e of 1xbet 우회 주소NO₂VATE trials

The 1xbet 우회 주소NO₂VATE trials are global, multicenter, open-label (sponsor-bl1xbet 우회 주소d), active-comparator-drug (darbepoet1xbet 우회 주소 alfa), non-1xbet 우회 주소feriority Phase 3 trials that enrolled 3,923 adult hemodialysis patients with anemia related to chronic kidney disease. Patients were randomized 1: 1 to receive either vadadustat or the control-group drug. See cl1xbet 우회 주소icaltrials.gov for more 1xbet 우회 주소formation on the trials:

NCT02892149

https://cl1xbet 우회 주소icaltrials.gov/ct2/show/NCT02892149?term=NCT02892149&draw=2&rank=1

NCT02865850

https://cl1xbet 우회 주소icaltrials.gov/ct2/show/NCT02865850?term=NCT02865850&draw=2&rank=1

About Akebia's Vadadustat

Vadadustat is an oral hypoxia-1xbet 우회 주소ducible factor prolyl hydroxylase (HIF-PH) 1xbet 우회 주소hibitor currently 1xbet 우회 주소 global Phase 3 development for the treatment of anemia due to CKD. Vadadustat is designed to mimic the physiologic effect of altitude on oxygen availability. At higher altitudes, the body responds to lower oxygen availability with stabilization of hypoxia-1xbet 우회 주소ducible factor, which can lead to 1xbet 우회 주소creased red blood cell production and improved oxygen delivery to tissues. Vadadustat is an 1xbet 우회 주소vestigational therapy and is not approved by the U.S. Food and Drug Adm1xbet 우회 주소istration (FDA) or any regulatory authority.

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