The FDA has approved Akebia Therapeutics’ vadadustat as a treatment for anaemia caused by chronic kidney disease (CKD) in dialysis patients, becoming the first rival to GSK’s Jesduvroq.

FDA已批准Akebia Therapeutics的vadadustat用于治疗透析患者慢性肾病（CKD）引起的贫血，成为葛兰素史克（GSK）Jesduvroq的第一个对手。

Akebia’s drug, which like Jesduvroq (daprodustat) is an oral HIF-PHI inhibitor, will be sold as Vafseo in the US and is now approved in 37 countries worldwide. It was previously turned down by the FDA in 2021, which was concerned by data potentially linking the drug to clotting complications and liver damage, allowing GSK to beat it to the US market..

Akebia的药物与Jesduvroq（daprodustat）一样，是一种口服HIF-PHI抑制剂，将在美国作为Vafseo销售，目前已在全球37个国家获得批准。此前，该药物于2021年被FDA拒绝，FDA担心该药物可能与凝血并发症和肝损伤有关，从而使葛兰素史克（GSK）在美国市场上击败了该药物。。

Both Jesduvroq and Vafseo provide an oral alternative to injectable therapies for anaemia based on recombinant erythropoietin (EPO), and are thought to stimulate the production of endogenous EPO in the body.

Jesduvroq和Vafseo都为基于重组促红细胞生成素（EPO）的贫血注射疗法提供了口服替代品，并被认为可以刺激体内内源性EPO的产生。

Anaemia is a common complication of CKD and can be exacerbated by dialysis, a treatment that aims to do the job of the kidneys by filtering the blood and removing excess fluid from it. There are estimated to be around 500,000 people who need dialysis for CKD at any time in the US, and almost 90% of dialysis patients are treated for anaemia.

贫血是CKD的常见并发症，透析会加剧贫血，透析是一种旨在通过过滤血液并清除多余液体来完成肾脏功能的治疗方法。据估计，在美国，任何时候都有大约50万人需要透析CKD，近90%的透析患者接受了贫血治疗。

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Vafseo can be used in patients who have been on dialysis for at least three months, a slightly shorter period than the four months required for GSK’s drug. Another oral HIF-PHI inhibitor, FibroGen’s Evrenzo (roxadustat), was also rejected by the FDA in 2021.

Vafseo可用于透析至少三个月的患者，比葛兰素史克药物所需的四个月略短。另一种口服HIF-PHI抑制剂FibroGen的Evrenzo（roxadustat）也于2021年被FDA拒绝。

Akebia hadn’t commented on its launch or pricing plans yet for the US at the time of writing, ahead of a conference call with analysts later today. It will sell Vafseo in the US market through its own commercial team and a partnership with CSL Vifor, a well-established provider of dialysis products..

在撰写本文时，阿克比亚尚未就其在美国的推出或定价计划发表评论，今天晚些时候将与分析师举行电话会议。它将通过自己的商业团队以及与CSL Vifor（一家成熟的透析产品供应商）的合作关系，在美国市场销售Vafseo。。

The company partners the drug with Medice Arzneimittel Pütter in Europe, where it was approved for CKD patients on dialysis last year, after an earlier alliance with Otsuka fell through. In Japan, meanwhile, Vafseo has been cleared for use in both dialysis and non-dialysis patients and is sold by Mitsubishi Tanabe..

该公司与欧洲的Medice Arzneimittel Pütter合作开发该药物，去年该药物被批准用于CKD透析患者，此前与大冢的合作失败。与此同时，在日本，Vafseo已被批准用于透析和非透析患者，并由三菱田边出售。。

Akebia’s president and chief executive John Butler has previously indicated that a US launch of vadadustat would represent the company’s most significant commercial opportunity and market of approximately $1 billion a year.

Akebia总裁兼首席执行官约翰·巴特勒（JohnButler）此前曾表示，在美国推出vadadustat将代表该公司最重要的商业机会和每年约10亿美元的市场。

There is also a considerable overlap between prescribers of Vafseo and Akebia’s only other approved therapy, Auryxia (ferric citrate) for iron deficiency anemia (IDA) and hyperphosphataemia (HP), which brought in $170 million in revenues last year.

Vafseo和Akebia唯一被批准的治疗缺铁性贫血（IDA）和高磷血症（HP）的耳聋（柠檬酸铁）的处方药之间也有相当大的重叠，去年带来了1.7亿美元的收入。

“At Akebia we are committed to kidney patients, a dedication that has driven our team to achieve this milestone,” said Butler. “We believe this commitment uniquely positions the company to execute a successful launch designed to drive toward a potential new oral standard of care for dialysis patients.”.

巴特勒说：“在阿克比亚，我们致力于肾脏病患者，这一奉献精神推动我们的团队实现了这一里程碑。”。“我们相信，这一承诺使该公司能够成功推出旨在推动透析患者潜在的新口服护理标准的产品。”。