艾加莫德(Efgartigimod) - 药物靶点：FcRn_在研适应症：免疫性血小板减少症，重症肌无力，慢性炎症性脱髓鞘性多发性神经病_专利_临床

概要

基本信息

药物类型

Fc片段

别名

Efgartigimod alfa、Efgartigimod Alfa (Genetical Recombination)、Efgartigimod alfa-fcab

+ [11]

靶点

FcRn

作用机制

FcRn拮抗剂(IgG受体FcRn大亚基p51拮抗剂)、免疫调节剂

治疗领域

肿瘤免疫系统疾病神经系统疾病+ [8]

在研适应症

免疫性血小板减少症重症肌无力慢性炎症性脱髓鞘性多发性神经病+ [15]

非在研适应症

巴西天疱疮

原研机构

argenx SE

在研机构

argenx SE

再鼎医药（上海）有限公司Argenx BV

+ [2]

非在研机构-

最高研发阶段批准上市

首次获批日期

美国 (2021-12-17),

重症肌无力

最高研发阶段(中国)批准上市

特殊审评优先审评 (美国)、快速通道 (美国)、孤儿药 (美国)、孤儿药 (欧盟)、优先审评 (中国)、突破性疗法 (中国)、儿科研究计划 (欧盟)、潜力创新药 (英国)

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序列信息

Sequence Code 18457995

来源: *****

关联

80

项与艾加莫德相关的临床试验

NCT06453694 / Not yet recruiting临床2期

A Pilot Randomized Trial of Efgartigimod Alfa for the Treatment of Incident Moderate to Severe Acute Optic Neuritis

The goal of this pilot clinical trial is to test efgartigimod alfa against placebo in adults with first-time optic neuritis (optic nerve inflammation). The main questions it aims to answer are:
Is it feasible to use efgartigimod alfa for optic neuritis?
Is it feasible to run a larger trial testing efgartigimod alfa in optic neuritis?
Does efgartigimod alfa work better than placebo in improving how quickly and how much vision returns?
Participants will:
have their vision and blood tested
be asked questions about their vision
will receive standard of care treatment with steroids regardless of whether they are receiving efgartigimod alfa or not
will have periodic visits over 6 months

开始日期2024-10-01

申办/合作机构

argenx SE

NCT06298565 / Not yet recruitingN/A

A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod Alfa

This is a non-interventional, prospective, post authorization safety study. Patients with gMG who are expected to start treatment with efgartigimod at enrolment or are within their first cycle of efgartigimod at enrolment will be eligible to enroll into the efgartigimod cohort. Patients with gMG who have not been exposed to efgartigimod and for whom it is not planned to start treatment with efgartigimod at enrolment will be eligible to enroll into the non-efgartigimod cohort.

开始日期2024-06-01

申办/合作机构

argenx SE

NCT06392386 / Not yet recruiting临床3期

An Open-label, Uncontrolled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod PH20 SC in Participants From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis

The purpose of this study is to measure the pharmacokinetics (PK), pharmacodynamics (PD), safety, tolerability, and immunogenicity of efgartigimod PH20 SC in pediatric participants with gMG aged 2 to <18 years. The primary goal is to confirm an appropriate dose of efgartigimod PH20 SC for pediatric patients using PK and PD results from this study. Participants will receive injections of efgartigimod PH20 SC and will be monitored for safety until the end of the study. At the end of the follow-up period, eligible participants may roll over to an open-label extension (OLE) study.

开始日期2024-05-31

申办/合作机构

argenx SE

100 项与艾加莫德相关的临床结果

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100 项与艾加莫德相关的转化医学

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100 项与艾加莫德相关的专利（医药）

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80

项与艾加莫德相关的文献（医药）

2024-04-01·European journal of neurology

Efgartigimod in generalized myasthenia gravis: A real‐life experience at a national reference center

Article

作者: Rinaldi, Elena ; Pinna, Alessandro ; Antozzi, Carlo ; Gallone, Annamaria ; Colasuonno, Anna ; Andreetta, Francesca ; Ciusani, Emilio ; Vanoli, Fiammetta ; Frangiamore, Rita ; Cheli, Marta ; Tramacere, Irene ; Mantegazza, Renato ; Bonanno, Silvia ; Maggi, Lorenzo

Abstract:

Background and purpose:

Inhibition of the neonatal Fc receptor (FcRn) for IgG is a promising new therapeutic strategy for antibody‐mediated disorders. We report our real‐life experience with efgartigimod (EFG) in 19 patients with generalized myasthenia gravis (gMG) along a clinical follow‐up of 14 months.

Methods:

EFG was administered according to the GENERATIVE protocol (consisting of a Fixed period of two treatment cycles [given 1 month apart] of four infusions at weekly intervals, followed by a Flexible period of re‐cycling in case of worsening). Eight patients were positive for acetylcholine receptor antibody, four for muscle‐specific tyrosine kinase antibody, and two for lipoprotein‐related protein 4 antibody, and five were classified as triple negative. Efficacy of EFG was assessed by the Myasthenia Gravis Activities of Daily Living, Myasthenia Gravis Composite, and Quantitative Myasthenia Gravis scales.

Results:

Fifty‐three percent of patients needed three treatment cycles, 26% needed four, and 21% needed five along the 14‐month clinical follow‐up. Meaningful improvement was observed at the end of each cycle with the clinical scores adopted. EFG had a dramatic effect on disease course, as during the year before treatment eight of 19 patients (42%) were hospitalized, and 15 of 19 (79%) needed treatment with plasma exchange or immunoglobulins; three of 19 (16%) were admitted to the intensive care unit. During EFG, none of the patients was hospitalized and only one patient required plasma exchange and intravenous immunoglobulins. No major side effects or infusion‐related reactions occurred.

Conclusions:

We observed that EFG was safe and modified significantly the course of the disease along a 14‐month follow‐up. Our experience strengthens the role of FcRn inhibition as an effective new tool for long‐term treatment of gMG.

2024-03-01·Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology

Efgartigimod improves triple-negative myasthenia gravis.

Letter

作者: Andreetta, Francesca ; Mantegazza, Renato ; Vanoli, Fiammetta ; Antozzi, Carlo ; Frangiamore, Rita ; Rinaldi, Elena

2024-03-01·American journal of clinical dermatology

Advancements in Bullous Pemphigoid Treatment: A Comprehensive Pipeline Update

Review

作者: Patsatsi, Aikaterini ; Karakioulaki, Meropi ; Eyerich, Kilian

ABASTRACT:

Bullous pemphigoid (BP) is a common autoimmune bullous disease affecting mainly the elderly, with rising incidence due to increased life expectancy. This disease is characterized by tense bullous lesions on normal or erythematous skin, accompanied by pruritus. BP pathogenesis involves autoantibodies against hemidesmosomal proteins BP180 and BP230, leading to detachment at the dermo-epidermal junction as well as blister formation. BP is associated with coexisting comorbidities and drug exposure, and its management often requires high doses or chronic use of systemic glucocorticoids, posing risks of adverse effects. This review focuses on novel treatment options for BP, exploring therapies targeting different immune pathways. Rituximab, a CD20 monoclonal antibody, depletes B-lymphocytes and has shown efficacy in severe cases. Dupilumab, targeting interleukin (IL)-4 receptor α and thus blocking IL-4 and IL-13, downregulates type 2 helper (Th2) responses and has demonstrated promising results. Targeting eosinophil-related molecules using bertilimumab and AKST4290 has yielded positive results in clinical trials. Omalizumab, an immunoglobulin (Ig) E antibody, can reduce disease severity and allows corticosteroid tapering in a number of cases. Complement inhibitors such as nomacopan and avdoralimab are being investigated. IL-17 and IL-23 inhibitors such as secukinumab and tildrakizumab have shown potential in a limited number of case reports. Neonatal Fc receptor antagonists such as efgartigimod are under investigation. Additionally, topical therapies and Janus kinase inhibitors are being explored as potential treatments for BP. These novel therapies offer promising alternatives for managing BP, with potential to improve outcomes and reduce high cumulative doses of systemic corticosteroids and related toxicities. Further research, including controlled clinical trials, is needed to establish their efficacy, safety, and optimal dosing regimens for BP management.

516

项与艾加莫德相关的新闻（医药）

2024-06-30

·赛柏蓝

2024年医保目录调整启动｜这些药品大降价

编者按：本文来自新康界，作者慧玲；赛柏蓝授权转载，编辑yuki 7月1日起，2024年医保药品目录调整正式开启申报工作。这是从2018年国家医保局成立以来，连续第七年的调整。实际上，每年医保目录调整前，药品降价已成为部分药企的常规操作。主动降价，也被视作相关药企积极参与医保谈判的诚意之举。据新康界统计，6月以来已有不少未进医保的药品主动申请降价，包括卡度尼利单抗、德曲妥珠单抗、维泊妥珠单抗、抗骨增生片等品种，降幅分别达到53.4%、22%、7%、6%。 6月部分主动下调价格的药品情况 01 未进医保，去年大卖近14亿在国家医保局发布目录调整信息后不久，有消息称，康方生物下调了其双抗新药卡度尼利单抗（开坦尼）的价格，单支价格从原先的13220元/125mg/瓶降至6166元/125mg/瓶，降幅53.4%。同日，康方生物确认了这一价格且取消赠药，称这一价格将给予患者购药更大灵活性，并表示将积极参加今年医保谈判。据悉，卡度尼利单抗上市后一直靠自费市场，此次降价后年治疗费用约为44万元，正好能挤入今年医保谈判的门槛。但康方生物表示，降价是为参加医保做出的调整。卡度尼利的年费用只是回到了没有赠药方案的水平，并不存在所谓大幅降价。目前康方正在积极筹备卡度尼利进医保的相关材料。抗癌药卡度尼利单抗是国内首个双特异性抗体，2022年6月，卡度尼利单抗踩线获批上市，但没有在当年进入医保目录，反而在自费市场表现十分亮眼。刚上市半年，卡度尼利单抗大卖5亿元，2023全年销售额达到13.58亿元，同比增长149%。仅从等级医院市场销售情况来看，卡度尼利单抗在2023年销售额同比上涨928.9%，达1.71亿元；2024年一季度销售4.7千万元。面对今年医保目录的调整，卡度尼利单抗似乎已做好准备。卡度尼利单抗全国等级医院销售情况截至2023年底，继国内第六个获批上市的PD-L1，同时也是第四个国产PD-L1——索卡佐利单抗年底获批上市后，目前国内共有17个获批上市的PD-(L)1产品，其中有11款PD-1、6款PD-L1，涉及超过10个瘤种和相关的泛瘤种。 17个产品中，有9个产品共22项申请正处于扩展新适应症的上市申请中，另外还有7个产品共计9项申请正在NDA新药首次上市申请中。然而2023年版（2024年1月开始执行）的医保目录中，只有4个国产品牌继续续约，未新增进口品牌或其他国产品牌进入目录。迫于PD-1竞争的愈演愈烈，康方生物或试图通过将卡度尼利单抗降价的方式，以减轻医保基金的压力，从而提高进医保概率。 02 多款重磅药物主动降价 2024年医保目录调整已然成为影响未来发展的风向标，包括PD-1、罕见病药物、慢病药物、抗病毒药物和新兴治疗领域等。 6月14日，据辽宁省药品和医用耗材集中采购网发布的《关于执行淡竹叶配方颗粒等175个药品主动降价结果的通知》，注射用维泊妥珠单抗药品价格从10400元/30mg/瓶主动降价至9580元/30mg/瓶，价格下降7%，虽调价幅度不大，但依据市场规则价格也有所松动。 6月19日，湖北省医疗保障局对近期主动申请下调挂网价的部分挂网药品进行了审核及公示。共包括98个主动下调价格的药品，如吉林一正药业的抗骨增生片，价格从403.2元/瓶下调至377.66/瓶，降幅达6%。值得一提的是，湖南科伦制药是此次降幅最为明显的企业。其上榜的注射用头孢曲松钠本身已是医保产品，价格从464元/2g下调至44.88元/2g、214.5元/1g下调至26.4元/1g，分别降幅达90%、88%。据悉，阿斯利康的德曲妥珠单抗也于近日主动申报药品降价，由原先的8860元/支降为6912元/支，降幅达22%，并同步取消慈善赠药，也展现出了参与新一轮医保谈判的决心。随着医保目录工作调整的开启，多个药品赶在6月30日之前压线获批，为国谈而努力。6月25日，国家药监局官网发布130个产品受理号获批，其中有26款新药、4个过评、超100个报产申请。其中几款产品都卡在了新国谈到来之际。如海思科的1类新药考格列汀片，用于2型糖尿病，是全球首个超长效DPP-4抑制剂且双周口服降糖药。此前已有恒瑞的瑞格列汀、科伦的曲格列汀，如今考格列汀片也加入了国内DDP4药物竞争。同样卡点新国谈资质的，还有绿叶制药的注射用罗替高汀微球、南京优科的氯维地平乳状注射液等。注射用罗替高汀微球每周给药一次，是全球首个治疗帕金森病的长效缓释微球制剂；南京优科的氯维地平乳状注射液是国内首家，用于高血压治疗。 03 18款罕见病药物有望纳入医保目录自诺西那生钠注射液国谈成功后，越来越多高值罕见病药被纳入国家医保目录，如2023年被纳入目录的艾加莫德α注射液(20ml:0.4g/瓶）、依库珠单抗注射液（30ml:300mg/瓶）。在纳入医保前，两款药物的价格分别为1.03万元/瓶、1.9万元/瓶，目前价格分别为0.56万元/瓶、0.25万元/瓶。价格降幅最低超40%，最高近80%。由于《第二批罕见病目录》的发布时间晚于2023年国家医保目录调整工作正式启动节点，因此2024年的国家医保目录调整是首次覆盖《第二批罕见病目录》相关病种。据统计，2023年及之前在国内获批已商业化的罕见病药中，共有27种罕见病的25种治疗药物未纳入医保，其中，18种药物在国内的年治疗费用为数十万元至百万元，这类罕见病药将成为2024年国家医保目录调整的重点关注对象。包括阿那白滞素注射液、布罗索尤单抗注射液、氯马昔巴特口服溶液、塞奈吉明滴眼液、依马利尤单抗注射液、注射用丹曲林钠、达妥昔单抗β注射液、那西妥单抗注射液和吸入用一氧化氮等。 END 内容沟通：郑瑶（13810174402）医药代表交流群扫描下方二维码加入银发经济市场机遇交流群扫描下方二维码加入左下角「关注账号」，右下角「在看」，防止失联

上市批准生物类似药

2024-06-29

·医药魔方

强生65亿美元收购的FcRn单抗治疗重症肌无力III期研究成功，递交上市在即

6月28日，强生宣布，Nipocalimab治疗全身性重症肌无力(gMG)患者的III期VIVACITY-MG3研究取得积极结果。Nipocalimab联合标准治疗（SOC）组患者24周内MG-ADL评分较基线的改善情况优于安慰剂联合SOC组，达到主要终点。强生表示将在今年晚些时候向监管机构递交资料。这项双盲安慰剂对照研究招募了大量AChR+，MuSK+和/或LRP4+患者，约占gMG患者总数的95%。在第22、23和24周接受Nipocalimab+SOC的患者MG-ADL较基线改善了4.70分，显著高于安慰剂+SOC的3.25分(P=0.002)。对于患有gMG的人来说，MG-ADL的1到2点变化可能是正常饮食和经常被食物噎住，或休息时呼吸急促和使用呼吸机之间的差异。该研究还达到了多个关键的次要终点: 在第22周和第24周，通过QMG测量不同肌肉群的力量和功能的改善情况，Nipocalimab+SOC组与安慰剂+SOC组相比，显著改善(P<0.001)；在第22、23和24周，与安慰剂+SOC相比，Nipocalimab+SOC的MG-ADL反应(比基线改善≥2点)显著更高(P=0.021)，进一步强调了Nipocalimab减轻gMG对患者日常生活影响的潜力。 Nipocalimab是一款在研的高亲和力、全人源、糖基化、无效应的单克隆抗体，可以选择性地阻断FcRn以降低循环免疫球蛋白G (IgG) 抗体的水平，包括导致多种疾病的自身抗体和异体抗体。 Nipocalimab最初由AnaptysBi开发，之后卖给了Momenta公司。2020年8月，强生以65亿美元价格收购Momenta，获得了这款药物。 gMG是一种慢性、终身性、罕见和高度衰弱的自身抗体驱动的神经肌肉疾病，其特征是波动性肌无力。此前，已有两款FcRn单抗获得FDA批准上市，分别是Argenx/再鼎的艾加莫德（efgartigimod）和优时比的rozanolixizumab，均已获批gMG适应症。艾加莫德已显示出良好的商业化前景，2022年是其在海外的第一个上市完整年，销售额便突破了4亿美元，2023年更是达到11.9亿美元，进入“重磅炸弹”行列。 Copyright © 2024 PHARMCUBE. All Rights Reserved. 欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。

并购临床3期临床成功临床结果上市批准

2024-06-28

·Firstwordpharma

J&J positions nipocalimab to rival Vyvgart after hitting mark in myasthenia gravis trial

Johnson & Johnson unveiled more details from a Phase III study of nipocalimab in generalised myasthenia gravis (gMG), adding another feather to its cap for the FcRn inhibitor programme. In addition to bolstering nipocalimab's potential in gMG, the results may also set the stage for a showdown with argenx's rival FcRn blocker Vyvgart (efgartigimod alfa), which was approved in 2021 for gMG patients who are positive for anti-AChR antibodies.Data from the VIVACITY-MG3 study, presented Friday at the European Academy of Neurology (EAN) conference, demonstrated superiority of nipocalimab over placebo in improving activities of daily living.The trial enrolled 199 adults with gMG, including 153 who were antibody-positive. Participants received either nipocalimab or placebo, both in addition to standard of care. Efficacy results showed that nipocalimab-treated patients achieved a 4.70-point improvement from baseline in the Myasthenia Gravis - Activities of Daily Living (MG-ADL) score over weeks 22, 23, and 24, compared to a 3.25-point improvement seen with placebo. The gap was statistically significant."For someone living with gMG, a one- to two-point change on MG-ADL may be the difference between normal eating and frequent choking on food, or shortness of breath at rest and being on a ventilator," the company said in its release.Key secondary endpoints were also met, including improvements in muscle strength and function as measured by the Quantitative Myasthenia Gravis (QMG) score over weeks 22 and 24. Further, a significantly greater proportion of nipocalimab-treated patients experienced ≥2-point improvement from baseline in MG-ADL response.Safety data were consistent with previous nipocalimab studies, with similar rates of serious adverse events and discontinuations between the nipocalimab and placebo groups.'Sizeable opportunity'J&J, which acquired the anti-FcRn antibody through its $6.5-billion takeout of Momenta Pharmaceuticals back in 2020, plans to submit regulatory filings for nipocalimab in gMG later this year, potentially setting up a competitive challenge to Vyvgart. Argenx's product generated $1.2 billion in 2023 sales.However, J&J aims to differentiate nipocalimab by highlighting its efficacy across a broader range of antibody-positive gMG patients, including those with anti-MuSK and anti-LRP4 antibodies, in addition to the more common anti-AChR antibodies. A recent Morgan Stanley note cited one key opinion leader (KOL) as seeing a "sizable opportunity" for nipocalimab in gMG, potentially as a second-line option for patients with incomplete response to Vyvgart. The KOL estimated that about 50% of Vyvgart patients could fit that portrait.The gMG success adds to nipocalimab's growing portfolio of positive clinical data across autoimmune indications. Earlier this month, J&J reported that nipocalimab had met its primary endpoint in a Phase II trial for Sjögren's disease. The drug has also shown promise in rare maternal-foetal disorders.

临床结果临床3期上市批准临床2期生物类似药

100 项与艾加莫德相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15270

研发状态

批准上市

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适应症	国家/地区	公司	日期
免疫性血小板减少症	日本	argenx SE	2024-03-26
重症肌无力	美国	arGEN-X BV	2021-12-17

未上市

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适应症	最高研发状态	国家/地区	公司	日期
慢性炎症性脱髓鞘性多发性神经病	申请上市	中国	再鼎医药（上海）有限公司	2024-04-24
大疱性类天疱疮	临床3期	美国	argenx SE	2023-03-22
大疱性类天疱疮	临床3期	美国	再鼎医药（上海）有限公司	2023-03-22
大疱性类天疱疮	临床3期	中国	argenx SE	2023-03-22
大疱性类天疱疮	临床3期	日本	再鼎医药（上海）有限公司	2023-03-22
大疱性类天疱疮	临床3期	日本	argenx SE	2023-03-22
大疱性类天疱疮	临床3期	澳大利亚	再鼎医药（上海）有限公司	2023-03-22
大疱性类天疱疮	临床3期	澳大利亚	argenx SE	2023-03-22
大疱性类天疱疮	临床3期	保加利亚	再鼎医药（上海）有限公司	2023-03-22
大疱性类天疱疮	临床3期	保加利亚	argenx SE	2023-03-22

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


MDA2024	N/A	重症肌无力 AChR positive \| MuSK positive \| seronegative	28	Efgartigimod weekly infusion	簾夢壓壓選築鹽廠製鏇(積艱鬱願淵衊齋鹹網製) = 鹽製壓艱築觸遞鏇憲壓膚淵憲獵憲窪鑰簾製鹽 (夢憲製壓齋壓鹹鏇鹹鹽 )	积极	2024-03-03
MDA2024	N/A	重症肌无力	-	Efgartigimod 10 mg/kg IV	積蓋簾觸鑰獵餘襯遞遞(繭顧遞鏇願夢夢壓願築) = 16% 糧鏇鏇衊艱蓋齋鏇繭鑰 (襯齋廠壓醖淵餘憲醖醖 ) 更多	-	2024-03-03
NCT04598451 (ADDRESS, Corporate Publications) 人工标引	临床3期	天疱疮	222	Efgartigimod	鏇選餘淵餘鏇襯醖鑰艱(淵選選襯窪鏇壓艱襯網) = 淵積鏇衊壓遞鬱網鑰獵觸願齋艱遞廠鏇選願鏇 (憲鏇構艱觸積構襯選顧 ) 未达到	不佳	2023-12-20
				Placebo	鏇選餘淵餘鏇襯醖鑰艱(淵選選襯窪鏇壓艱襯網) = 鏇鹽網蓋膚願積觸鬱構觸願齋艱遞廠鏇選願鏇 (憲鏇構艱觸積構襯選顧 ) 未达到
NCT04188379 (ADVANCE IV, ASH2023)	临床3期	免疫性血小板减少症维持	131	Efgartigimod IV 10 mg/kg	遞觸憲窪窪艱衊繭願繭(糧蓋艱窪廠網膚積鹽醖) = 餘築夢範糧廠獵範製願鏇襯範膚獵選願獵鬱鑰 (積壓積觸鑰憲壓獵窪淵 ) 更多	积极	2023-12-11
				Placebo IV	遞觸憲窪窪艱衊繭願繭(糧蓋艱窪廠網膚積鹽醖) = 襯窪餘鏇顧鹽憲積憲膚鏇襯範膚獵選願獵鬱鑰 (積壓積觸鑰憲壓獵窪淵 ) 更多
ADVANCE-IV (NEWS) 人工标引	N/A	血小板减少症	-	VYVGART	襯鏇網構壓淵憲簾衊艱(壓壓範築壓鹽鹽觸餘鑰) = 觸淵鏇蓋簾簾蓋構網構衊構網顧鹽膚廠積襯蓋 (廠衊餘艱蓋衊遞鹹鬱構 )	积极	2023-11-28
				placebo	襯鏇網構壓淵憲簾衊艱(壓壓範築壓鹽鹽觸餘鑰) = 獵遞顧鬱選築壓鹹鏇獵衊構網顧鹽膚廠積襯蓋 (廠衊餘艱蓋衊遞鹹鬱構 )
ADAPT (GlobeNewswire) 人工标引	N/A	重症肌无力	-	VYVGART	餘鏇遞蓋壓壓壓獵構襯(鹽築構鑰衊餘繭願艱範) = data illustrate the ability of VYVGART to provide consistent, repeatable, and clinically meaningful responses across more than 19 cycles, including improvements in quality-of-life measures, for anti-acetylcholine receptor (AChR) antibody positive patients with gMG 艱鹹積襯壓餘願顧選膚 (襯鬱網蓋築鬱膚壓構網 ) 更多	积极	2023-11-01
				VYVGART Hytrulo
ADAPT, ADVANCE, ADAPT+ (EADV2023)	临床2/3期	自身免疫性疾病	-	Efgartigimod	願餘鹹繭鬱簾壓鹹鬱壓(製夢鹽壓壓壓獵簾鏇範) = 膚繭艱鏇選選製觸壓觸艱齋衊糧窪網鏇淵鑰壓 (鬱憲鏇簾憲範遞廠廠膚 ) 更多	积极	2023-10-11
				Placebo	願餘鹹繭鬱簾壓鹹鬱壓(製夢鹽壓壓壓獵簾鏇範) = 鑰夢齋構醖齋獵範衊顧艱齋衊糧窪網鏇淵鑰壓 (鬱憲鏇簾憲範遞廠廠膚 ) 更多
NCT03770403 (CTgov)	临床3期	重症肌无力 \| 肌肉无力	151	Efgartigimod	獵願繭觸廠遞艱醖顧襯(網鏇艱網鬱壓淵艱遞艱) = 構鬱衊獵膚鬱襯鑰鑰齋積憲膚願鹹膚製網選鏇 (餘壓夢膚構壓網襯憲餘, 鑰構衊鑰繭蓋鹽鬱醖夢 ~ 顧構夢膚願窪選壓齋憲) 更多	-	2023-07-14
ADAPT+ (AAN2023)	临床3期	重症肌无力 anti-AChR-Ab+	167	Efgartigimod 10 mg/kg	淵獵壓鬱廠窪餘網鑰簾(糧糧築鏇餘構艱鏇範壓) = 15% 艱醖簾鑰製範構鑰鏇鏇 (衊鏇壓願襯簾憲範鏇鹽 ) 更多	积极	2023-04-25
ADAPT study (AAN2023)	N/A	重症肌无力 AChR-Ab+	-	Efgartigimod 10 mg/kg	製範餘廠範夢齋築簾網(窪鹽願獵遞網鏇鏇窪憲) = Adverse events were mostly mild-moderate and included headache, nasopharyngitis, nausea, diarrhea, and upper respiratory/urinary tract infection 網顧鏇顧醖鹹窪製憲鏇 (憲蓋鏇網鹹選憲蓋艱襯 )	-	2023-04-25
				Placebo