The Food and Drug Administration on Tuesday

食品和药物管理局于周二

granted accelerated approval

授予加速批准

to Otsuka Pharmaceutical's injectable medicine, the first in a class of medicines for a rare, potentially life-threatening kidney disease.

对于大冢制药的注射药物，这是用于治疗一种罕见的、可能危及生命的肾脏疾病的一类药物中的第一种。

The new medicine, known as Voyxact, is now approved for its ability to reduce protein in the urine of people with IgA nephropathy, or IgAN, an autoimmune disease that causes protein to build up in the kidneys and that can lead to failure of the organ. Voyxact comes as a self-administered, subcutaneous injection given every four weeks.

新型药物Voyxact现已获批，它能够减少IgA肾病（IgAN）患者尿液中的蛋白质。IgA肾病是一种自身免疫性疾病，会导致蛋白质在肾脏中积累，可能引发器官衰竭。Voyxact为每四周一次的自我皮下注射剂型。

Otsuka did not disclose pricing..

大冢制药并未透露定价。

“The availability of Voyxact represents a novel targeted approach to help manage this complex disease for patients living with IgAN,” said John Kraus, executive vice president and chief medical officer of Otsuka, in a statement.

“Voyxact 的问世为管理这种复杂疾病提供了新的靶向方法，有助于 IgAN 患者应对病情，”大冢制药执行副总裁兼首席医疗官约翰·克劳斯在一份声明中表示。

Several therapies exist to treat IgAN. However, because the disease still leads to kidney function decline, demand remains for new treatments. Some

几种疗法可用于治疗IgAN。然而，由于该疾病仍导致肾功能下降，对新疗法的需求依然存在。一些

estimates

估计

hold that up to 130,000 people in the U.S. have the disease, presenting a market opportunity in the range of $6 billion to $10 billion, according to Jefferies analyst Farzin Haque.

据杰富瑞分析师法扎因·哈克称，美国约有13万人患有此病，这带来了60亿至100亿美元的市场机会。

Such an opportunity has attracted interest from large drugmakers like

这样的机会已经吸引了像大型制药公司这样的兴趣，

Vertex Pharmaceuticals

顶点制药公司

,

，

Biogen

百健公司

and

和

Novartis

诺华

.

。

Otsuka acquired

大冢收购了

Voyxact, scientifically known as sibeprenlimab, through

Voyxact，科学名称为sibeprenlimab，通过

a 2018 buyout

2018年收购

of Visterra. The drug works by blocking a protein called A-proliferation-inducing-ligand, or APRIL, which plays a key role in the development and progression of IgAN.

Visterra公司。该药物通过阻断一种称为A-增殖诱导配体（APRIL）的蛋白质起作用，这种蛋白质在IgAN的发病和发展中起关键作用。

Supporting the approval are interim results from a late-stage study, in which Voyxact reduced proteinuria levels by 51% after nine months compared to a 2% increase in a placebo group. The most common side effects observed were infections and injection site reactions.

支持批准的是晚期研究的中期结果，其中Voyxact在九个月后将蛋白尿水平降低了51%，而安慰剂组则增加了2%。观察到的最常见副作用是感染和注射部位反应。

The study is still ongoing to evaluate a change in kidney function measured by “estimated glomerular filtration rate,” or eGFR, over 24 months. Data is expected in 2026.

该研究仍在进行中，以评估通过“估算肾小球滤过率”（eGFR）测量的肾功能在24个月内的变化。预计数据将在2026年公布。

Other drugs with the same mechanism may arrive on market in the coming years. Most notably, Voyxact could compete with atacicept, a drug from

其他具有相同机制的药物可能会在未来几年内上市。最值得注意的是，Voyxact可能与atacicept竞争，

Vera Therapeutics

薇拉治疗公司

that targets APRIL as well as a protein called B cell activating factor, or BAFF.

该药物靶向APRIL以及一种名为B细胞活化因子（BAFF）的蛋白质。

In a note to clients, Leerink’s Haque argued that Voyxact’s labeling bodes well for Vera, as it omits a urine protein/creatinine cutoff, “breaking precedent set by four prior accelerated approvals,” which would have restricted use to a smaller patient population.

在给客户的一份报告中，Leerink 的哈克认为，Voyxact 的标签对 Vera 来说是个好兆头，因为它省略了尿蛋白/肌酐的临界值，“打破了此前四次加速审批的先例”，否则使用范围将受到限制，仅适用于较小的患者群体。

Vera

维拉

submitted the drug to the FDA earlier this month

本月初向FDA提交了该药物

. If approved, it could join enter the market as soon as next year.

如果获得批准，它可能最早在明年进入市场。