Johnson & Johnson's FcRn inhibitor nipocalimab has been awarded fast-track status by the FDA as a treatment for Sjogren's disease (SjD), an autoimmune condition that affects millions of people worldwide but has no treatments that address the underlying cause.

强生公司的FcRn抑制剂nipocalimab已被FDA授予快速通道资格，用于治疗干燥综合症（SjD），这是一种影响全球数百万人的自身免疫性疾病，目前尚无针对其根本病因的治疗方法。

The new status adds to the earlier breakthrough designation for the drug and comes as J&J is waiting for the results of its first phase 3 trial in moderate-to-severe SjD – called DAFFODIL – which started in December.

新认定是对该药物此前获得的突破性疗法认定的补充。目前，强生公司正在等待其中重度 SjD III 期临床试验 DAFFODIL 的结果，该试验于去年 12 月开始。

Last year, J&J reported results from the phase 2 DAHLIAS trial which showed improvements in various measures of SjD disease activity with

去年，J&J报告了2期DAHLIAS试验的结果，结果显示SjD疾病活动性的各种指标有所改善。

nipocalimab

尼泊卡利单抗

compared to placebo.

与安慰剂相比。

SjD is characterised by the production of auto-antibodies, leading to chronic inflammation that leads to dryness in mucosal surfaces like the eyes and mouth and affects around 4 million people worldwide. It can also cause damage to organs, including the joints, lungs, kidneys, and nervous system, and raises the risk of B-cell lymphomas by 20 times, leading to an increased risk of early death..

SjD 的特点是会产生自身抗体，导致慢性炎症，从而引起眼睛和口腔等黏膜表面的干燥，并影响全球约 400 万人。它还可能对关节、肺、肾脏和神经系统等器官造成损害，并使 B 细胞淋巴瘤的风险增加 20 倍，进而提升早逝的风险。

Nipocalimab has been described by J&J as a 'Swiss army knife' for autoimmune diseases, with a long list of potential indications that includes

强生公司将尼波卡利单抗描述为自身免疫性疾病的“瑞士军刀”，其潜在适应症列表很长，包括

generalised myasthenia gravis

全身性重症肌无力

(gMG), warm autoimmune haemolytic anaemia (wAIHA), and chronic inflammatory demyelinating polyneuropathy (CIDP), amongst others. It is also in mid-stage testing for more common disorders including rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE).

（gMG）、温抗体型自身免疫性溶血性贫血（wAIHA）和慢性炎性脱髓鞘性多发性神经病（CIDP）等。它还处于针对更常见疾病如类风湿关节炎（RA）和系统性红斑狼疮（SLE）的中期测试阶段。

The company has previously suggested that the drug could become a $5 billion-a-year product, despite trailing behind other drugs in the FcRn inhibitor class – Argenx's Vyvgart (efgartigimod alfa) family and UCB's Rystiggo (rozanolixizumab) – which have already reached the market for gMG and are in clinical testing for various other indications..

该公司此前曾表示，尽管该药物在 FcRn 抑制剂类药物中落后于其他药物——Argenx 的 Vyvgart（艾夫加替莫德阿尔法）系列和 UCB 的 Rystiggo（罗扎诺利珠单抗）——这些药物已经进入 gMG 市场，并正在进行针对其他多种适应症的临床试验，但该药物仍可能成为一款年销售额达 50 亿美元的产品。

Nipocalimab has been filed for gMG in the US and was awarded a priority review in January, setting up an FDA decision in the summer.

尼波卡利单抗已在美国提交用于治疗gMG，并于一月获得优先审查，预计FDA将在夏季作出决定。

In a statement, J&J said that the drug is the first biologic to get breakthrough status from the FDA, and alongside the fast-track status should 'accelerate the delivery' of the drug for SjD patients.

强生公司在一份声明中表示，该药是首个获得美国食品和药物管理局突破性疗法认定的生物制品，加上快速通道资格，应该能够“加速”将该药提供给干燥综合症患者。

'This marks an additional important step forward in our efforts to bring meaningful advancements to people living with Sjögren's disease, a serious and debilitating condition,' said Katie Abouzahr, head of J&J's autoantibody portfolio and maternal foetal disease area leader.

“这标志着我们在为患有干燥综合症（一种严重且使人衰弱的疾病）的人们带来有意义的进展方面又迈出了重要的一步，”强生公司自体抗体组合负责人兼母胎疾病领域领导者凯蒂·阿布扎赫表示。

'We look forward to continuing to work closely with the FDA to advance the clinical development of nipocalimab and potentially provide a much-needed treatment option for this community.'

“我们期待继续与FDA密切合作，推进尼波卡利单抗的临床开发，为这个群体提供一个亟需的治疗选择。”

Argenx also has SjD in its sights for Vyvgart and is currently running the phase 3 Unity trial, which also started last December and followed proof-of-concept data with its subcutaneously administered Vyvgart Hytrulo formulation of the drug.

Argenx 也将 SjD 作为 Vyvgart 的目标适应症，并正在开展第三阶段的 Unity 试验，该试验同样于去年十二月启动，并在其皮下注射型 Vyvgart Hytrulo 药物配方的概念验证数据基础上进行。