Cyclosporine

The FDA has approved Johnson & Johnson's anti-FcRn antibody, nipocalimab, for the treatment of generalized myasthenia gravis. The drug will be sold under the brand name IMAAVY. This approval positions J&J to challenge leading competitors in the myasthenia gravis market, such as AstraZeneca, which markets the monoclonal antibodies SOLIRIS and ULTOMIRIS. J&J will also be competing with Argenx's VYVGART and UCB's RYSTIGGO and ZILBRYSQ. LAS VEGAS, May 22, 2025 /PRNewswire/ -- Myasthenia gravis is an autoimmune disorder in which antibodies disrupt the communication between nerves and muscles, resulting in skeletal muscle weakness. This weakness primarily affects voluntary muscles that control eye movement, facial expression, swallowing, and limb function. The condition is predominantly driven by autoantibodies targeting either the acetylcholine receptor (AChR-Ab) or a receptor-associated protein known as muscle-specific tyrosine kinase (MuSK-Ab). According to DelveInsight's analysis, there were approximately 300,000 diagnosed prevalent cases of myasthenia gravis across the 7MM in 2024. This number is expected to grow steadily over the forecast period (2025–2034), with a projected CAGR. The current myasthenia gravis therapeutics market mainly consists of symptomatic treatments such as acetylcholinesterase inhibitors like Mestinon. However, achieving full clinical remission with symptomatic therapy alone is challenging. As a result, immunosuppressive drugs are frequently introduced. First-line immunotherapy typically involves high-dose oral corticosteroids such as prednisone or prednisolone, which can induce a rapid response within 2 to 4 weeks. To reduce reliance on steroids and improve long-term disease control, nonsteroidal immunosuppressants (NSISTs) are often used. These include antimetabolites (e.g., azathioprine, mycophenolate mofetil, methotrexate, and cyclophosphamide) and calcineurin inhibitors (e.g., tacrolimus and cyclosporine). While NSISTs may be used as standalone treatments, they usually take 6 to 9 months to produce noticeable effects. Immunomodulatory therapies, including intravenous immunoglobulin (IVIg) and plasmapheresis (PLEX), are typically reserved for acute exacerbations or myasthenic crises. They are also employed as chronic treatments in patients who cannot tolerate or do not respond to standard immunosuppressants. Although traditional immunosuppressive strategies can help manage symptoms, achieving long-term, stable remission remains difficult. Additionally, about 15% of patients are considered treatment-refractory, meaning they either fail to respond to or cannot tolerate multiple immunosuppressive options. These patients often face the dual challenge of persistent symptoms and the adverse effects of long-term immunosuppression. Learn more about the myasthenia gravis disease market @ Myasthenia Gravis Treatment Medications The myasthenia gravis treatment market is well-established, with multiple approved drugs for myasthenia gravis, including SOLIRIS, ULTOMIRIS, RYSTIGGO, ZILBRYSQ, and VYVGART, among others. Alexion Pharmaceuticals' SOLIRIS is a monoclonal antibody that targets and inhibits complement protein C5, thereby blocking the formation of the terminal complement complex. This action helps reduce complement-driven hemolysis in PNH and thrombotic microangiopathy in aHUS. Although its exact mechanism in gMG and NMOSD is not fully known, it is believed to decrease complement complex accumulation. Between 2017 and 2023, SOLIRIS gained regulatory approvals in Japan, the US, and the EU for treating gMG, including pediatric indications in Japan. ULTOMIRIS (ravulizumab), also from Alexion Pharmaceuticals, is the first long-acting C5 inhibitor, offering rapid, complete, and sustained suppression of complement activity. It binds to C5, preventing its cleavage and subsequent formation of the membrane attack complex (C5b-9). ULTOMIRIS is effective in managing terminal complement-mediated hemolysis in PNH and thrombotic microangiopathy in aHUS. Although the precise mechanism in gMG and NMOSD remains unclear, it is thought to reduce complement deposition at the neuromuscular junction and block aquaporin-4 antibody-mediated complement activation. It received approvals from the US FDA, EMA, and Japan's PMDA in 2022. Get an in-depth assessment on generalized myasthenia gravis medication for adults @ ULTOMIRIS vs SOLIRIS for Myasthenia Gravis UCB Biopharma's RYSTIGGO is a subcutaneously administered, humanized monoclonal antibody that binds with high affinity to the human neonatal Fc receptor (FcRn). It received regulatory approval from the US FDA and Japan's PMDA in 2023, followed by the EC in January 2024. ZILBRYSQ, also developed by UCB Biopharma, is the first once-daily subcutaneous peptide-based inhibitor specifically targeting complement protein C5. It works by blocking C5 cleavage and the formation of the terminal complement complex C5b-9. Although its precise action in gMG remains uncertain, it is thought to limit C5b-9 accumulation at the neuromuscular junction. ZILBRYSQ gained approval from the US FDA, EMA, and PMDA in 2023. VYVGART, from Argenx, is a human IgG1 antibody fragment that targets FcRn, leading to a decrease in circulating IgG autoantibodies. It is the first FcRn blocker to receive regulatory approval. Argenx's VYVGART HYTRULO (also marketed as VYVDURA) combines efgartigimod alfa, an FcRn inhibitor, with hyaluronidase, an endoglycosidase, for treating adults with generalized myasthenia gravis. This formulation was approved by the US FDA and EMA in 2023 and by the PMDA in January 2024. Uncover the mechanism of FcRn inhibitor myasthenia gravis medication @ Myasthenia Gravis MoA On April 30, 2025, the FDA approved Johnson & Johnson's nipocalimab, branded as IMAAVY, as a new therapy for gMG. This approval puts IMAAVY among the list of approved drugs for myasthenia gravis treatment. The approval, which J&J says encompasses the widest eligible patient population with gMG, includes individuals aged 12 and above who test positive for AChR or anti-muscle-specific kinase (MuSK) antibodies. IMAAVY functions by inhibiting the FcRn protein, which plays a role in maintaining circulating IgG antibodies, key drivers in many autoimmune disorders. By blocking FcRn, IMAAVY significantly reduces harmful IgG autoantibodies while preserving the body's overall immune response, according to clinical data. J&J sees broader potential for IMAAVY beyond gMG, believing its mechanism of action could apply across multiple autoimmune conditions due to IgG's involvement in various diseases. The FDA's decision followed results from the ongoing Phase III Vivacity-MG3 trial, which evaluates IMAAVY in combination with standard care versus placebo and standard care in 199 adult gMG patients, including 153 antibody-positive individuals. Additionally, J&J is conducting a Phase II/III pediatric trial called Vibrance, where IMAAVY, combined with standard care, achieved its primary goal by reducing total serum IgG levels by 69% over 24 weeks. J&J acquired IMAAVY through its USD 6.5 billion acquisition of Momenta Pharmaceuticals in 2020, with the FcRn inhibitor myasthenia gravis serving as the centerpiece of that deal. The company is aiming for blockbuster status, forecasting peak annual sales of over USD 5 billion for the myasthenia gravis medication. Dive deep into the myasthenia gravis treatment cost @ Generalized Myasthenia Gravis Drug with Copay Myasthenia gravis pipeline possesses some drugs in mid- and late-stage development to be approved in the near future. The expected launch of myasthenia gravis treatment medications, such as Batoclimab (Immunovant Sciences GmbH), Descartes-08 (Cartesian Therapeutics), and others, are expected to further create a positive impact on the myasthenia gravis disease market. Discover which therapies are expected to grab major myasthenia gravis therapeutics market share @ Market Analysis on Myasthenia Gravis Batoclimab is a fully humanized monoclonal antibody designed to inhibit neonatal Fc receptors by blocking the interaction between FcRn and IgG, thereby promoting the breakdown of autoantibodies. It has received Orphan Drug Designation (ODD) from both the US FDA and the EMA. In March 2025, Immunovant announced topline results from its Phase III trial evaluating batoclimab in patients with myasthenia gravis. Descartes-08 represents the first RNA-engineered CAR T-cell (rCAR-T) therapy developed for autoimmune conditions. This therapy uses cytotoxic T-cells programmed to target and eliminate pathogenic plasma cells that produce autoantibodies. Created from a patient's own blood, Descartes-08 has also received ODD from the US FDA for treating myasthenia gravis. In December 2024, Cartesian Therapeutics shared encouraging updated findings from its Phase IIb study of Descartes-08 in myasthenia gravis. Furthermore, in January 2025, the FDA agreed to the company's Phase III AURORA trial design under a Special Protocol Assessment, with trial initiation planned for the first half of 2025. Curious about what the new myasthenia gravis treatments are in development? Visit Myasthenia Gravis Clinical Trials The anticipated launch of these emerging myasthenia gravis treatments are poised to transform the market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the myasthenia gravis market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. DelveInsight estimates that the myasthenia gravis market size in the 7MM is expected to grow from USD 5.2 billion in 2024 at a significant CAGR by 2034. According to DelveInsight's analysis, the myasthenia gravis market growth is anticipated with the introduction of emerging therapies, leading to an expansion in the myasthenia gravis market size throughout the forecast period (2025–2034). This anticipated myasthenia gravis market growth is driven by advancements in treatment options, greater healthcare access, and a rising myasthenia gravis prevalence, which together foster higher demand for innovative and effective therapies. DelveInsight's latest published market report titled Myasthenia Gravis Market Insight, Epidemiology, and Market Forecast – 2034 will help you to discover which myasthenia gravis treatment market leader is going to capture the largest market share. The report provides comprehensive insights into the country-specific myasthenia gravis treatment guidelines, patient pool analysis, and epidemiology forecast to help understand the key opportunities and assess the market's underlying potential. The myasthenia gravis market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM, segmented into: Total Diagnosed Prevalent Cases of Myasthenia Gravis Gender-specific Diagnosed Prevalent Cases of Myasthenia Gravis Age-specific Diagnosed Prevalent Cases of Myasthenia Gravis Diagnosed Prevalent Cases of Myasthenia Gravis by MGFA Classification Diagnosed Prevalent Cases of Generalized Myasthenia Gravis by Antibody Serology The report provides an edge while developing business strategies by understanding trends shaping and driving the 7MM myasthenia gravis market. Highlights include: 10-year Forecast 7MM Analysis Epidemiology-based Market Forecasting Historical and Forecasted Market Analysis upto 2034 Emerging Drug Market Uptake Peak Sales Analysis Key Cross Competition Analysis Industry Expert's Opinion Access and Reimbursement Download this myasthenia gravis market report to assess the epidemiology forecasts, understand the patient journeys, know KOLs' opinions about the upcoming treatment paradigms, and determine the factors contributing to the shift in the myasthenia gravis market. Also, stay abreast of the mitigating factors to improve your market position in the myasthenia gravis therapeutic space. Related Reports Myasthenia Gravis Epidemiology Forecast Myasthenia Gravis Epidemiology Forecast – 2034 report delivers an in-depth understanding of the disease, historical and forecasted myasthenia gravis epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Myasthenia Gravis Pipeline Myasthenia Gravis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key myasthenia gravis companies, including Harbour BioMed (Guangzhou) Co. Ltd., Kyverna Therapeutics, Cabaletta Bio, Takeda, Hoffmann-La Roche, Immunovant Sciences GmbH, Regeneron Pharmaceuticals, Novartis Pharmaceuticals, Janssen Research & Development, LLC, Momenta Pharmaceuticals, Inc., Amgen, Dianthus Therapeutics, Cartesian Therapeutics, COUR Pharmaceutical Development Company, Inc., Alexion Pharmaceuticals, Inc., among others. Generalized Myasthenia Gravis Market Generalized Myasthenia Gravis Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key gMG companies including Alexion Pharmaceuticals, Argenx, UCB Biopharma, Argenx-Halozyme Therapeutics, Horizon Therapeutics, Hoffmann-La Roche, Janssen Research & Development, LLC, Immunovant Sciences GmbH, Bristol Myers Squibb, Biogen Inc., Pfizer Inc., Novartis AG, Sanofi S.A., Roche Holding AG, Johnson & Johnson, Takeda Pharmaceutical Company Limited, AbbVie Inc., Eli Lilly and Company, Merck & Co., Inc., GlaxoSmithKline plc, AstraZeneca plc, Amgen Inc., Boehringer Ingelheim International GmbH, Genentech, Inc., Gilead Sciences, Inc., Celgene Corporation, Vertex Pharmaceuticals Incorporated , among others. Generalized Myasthenia Gravis Pipeline Generalized Myasthenia Gravis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key gMG companies, including Biocon, Cartesian Therapeutics, UCB, Momenta Pharmaceuticals, HanAll Biopharma, Roche, Alexion, Novartis, Takeda, BioMarin, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . 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近期，国家药监局批准中山康方生物申报的依若奇单抗注射液（商品名：爱达罗）上市。资料显示，依若奇单抗注射液是一款全人源IgG1单克隆抗体，适用于对环孢素、甲氨蝶呤（MTX）等其他系统性治疗或PUVA（补骨脂素和紫外线A）不应答、有禁忌或无法耐受的中度至重度斑块状银屑病的成年患者的治疗。依若奇单抗注射液是国内首个针对IL-12和IL-23p40全人源单克隆抗体，有望成为银屑病患者的治疗新选择。1.双雄争霸银屑病的确切病因尚未完全阐明，一般认为遗传、免疫与环境因素在银屑病的发生中发挥重要作用。IL-12及IL-23是炎症反应及免疫反应中自然产生的细胞因子，拥有共同的p40亚基，其中IL-12诱导Th1细胞（辅助性T细胞1）增殖并释放干扰素与TNF-α（肿瘤坏死因子α），IL-23诱导Th17细胞（辅助性T细胞17）发育并释放IL-17（白介素-17）等，这些细胞因子均可刺激角质形成细胞的增生，导致银屑斑块的形成。IL-12/23抑制剂通过靶向IL-12和IL-23的p40亚基并与之结合，同时抑制IL-12和IL-23与细胞表面受体的相互作用，进而减少T细胞对干扰素、TNF-α、IL-17等相关细胞因子的释放，阻断各自介导的细胞免疫反应，从而抑制银屑病的异常免疫反应；同时不影响其他来源的IL-17发挥正常生理功能，如不影响其他免疫细胞分泌的IL-17行使的维持胃肠道黏膜稳态的功能。图1 IL-12/IL-23信号通路图片来源：文献资料目前，全球共有两款IL-12/IL-23抑制剂药物上市，两种药物均已在国内获批，即康方生物的依若奇单抗和强生的乌司奴单抗，此外全球有2款IL-12/IL-23靶点相关新药在研。表1 IL-12/IL-23抑制剂竞争格局数据来源：药智数据，药智咨询整理乌司奴单抗由强生开发，是全球首款上市的IL-12/IL-23抑制剂，于2009年9月获FDA批准上市，商品名Stelara，目前已经先后在美国获批了银屑病、克罗恩病等五个适应症。得益于广泛的适应症覆盖和出色的临床数据，乌司奴单抗2022年全球销售额达到97亿美元，成为强生销量最高的产品，在自免领域销售额仅次于阿达木单抗。乌司奴单抗于2017年11月在国内获批上市，商品名喜达诺，目前已在国内先后被批准用于成人斑块状银屑病、儿童斑块状银屑病及克罗恩病3项适应症。乌司奴单抗氨基酸序列在中国的专利已于2021年8月到期，国内首个生物类似药华东医药的赛乐信目前已于2024年11月获批上市，百奥泰、石药集团的同类品种也已先后递交国内上市申请并获得受理。依若奇单抗通过阻断细胞因子IL-12和IL-23的生物学活性，以达到临床治疗自身免疫性疾病的作用。依若奇单抗的III期研究结果显示，接受依若奇单抗注射液135mg第0、4周2针注射疗效优异，每12周1次（Q12W）维持治疗，疗效可长期稳定，至第52周的PASI 75仍高达77.9%；治疗16周因皮肤疾病困扰对患者生活质量的影响程度下降超过55%，治疗第52周进一步下降至超过65%。依若奇单抗给药频次少，每年仅需4次，有助于提高患者的用药依从性。依若奇单抗安全性良好，治疗患者的不良事件发生率较低且数值低于安慰剂。2.市场急需银屑病是一种以皮肤和关节为主的慢性、复发性、炎症性、系统性疾病，临床表现为鳞屑性红斑或斑块，局限或广泛分布。流行病学调查研究显示，银屑病是临床常见的慢性皮肤病，全球约1.25亿人患有银屑病，2008年中国6省市银屑病流行病学调查结果为0.47%，估计目前全国有约700万人患银屑病。银屑病作为系统性疾病，可与多种全身性、代谢性疾病并发，57.9%的银屑病患者至少合并1种银屑病共病，合并症包括心血管疾病、糖尿病、高血压、代谢综合征等多种疾病。银屑病可分为斑块型银屑病、点滴型银屑病、反向型银屑病、脓疱型银屑病等，其中斑块型银屑病约占90%。银屑病复发或加重的最常见诱发因素为季节变化，其中冬季复发或加重者占48.8%，春季占23.1%，秋季占17.1%，夏季占8.4%。银屑病目前尚不能根治，其治疗目的为实现症状和皮损的完全清除或几乎完全清除，主要包括控制及稳定病情，减缓疾病发展进程，抑制皮损加重及瘙痒，避免疾病复发及加重，控制相关的并发症等。目前银屑病的治疗方案依据疾病的严重程度而制定，外用药物是轻度或局部银屑病患者的主要治疗手段，主要包括糖皮质激素和钙调磷酸酶抑制剂；中重度银屑病的治疗方案包括光疗和系统药物治疗，系统药物包括传统口服药物如甲氨蝶呤、环孢素等，生物制剂如TNF-α抑制剂、IL-12/23抑制剂等和小分子靶向药托法替布等。目前的银屑病治疗药物仍无法覆盖银屑病患者的全部临床需求。全国银屑病患者中中重度银屑病患者占患者的67.0%，患者数约为500万。有研究显示，传统口服药物具有一定的短期疗效，但对重要脏器不良反应风险过高，我国最新的银屑病诊疗指南不推荐传统口服药物用于长期治疗；生物制剂具有较强的短期疗效优势，但是长期治疗面临疗效降低，存在一定的感染和矛盾性皮肤反应风险，注射给药方式导致注射局部反应和治疗不便利性等挑战。因此，银屑病治疗仍存在巨大的未满足的临床需求。3.结语依若奇单抗作为国内首个自主原研的IL-12/IL-23抑制剂，填补了银屑病治疗领域的空白，为中重度患者提供高效、安全的新选择。其独特的靶向机制显著抑制异常免疫反应，年给药仅4次，极大提升依从性。III期研究显示疗效持久，安全性优于传统药物，且对比国际竞品更具本土优势。随着国内生物类似药研发加速，依若奇单抗的上市不仅缓解临床需求，更推动自免领域创新，为患者带来长期治疗希望。#康方生物 #依若奇单抗 #银屑病参考来源：1.药智数据2.中国银屑病诊疗指南（2023版）3.江慧姗,王卫亮.银屑病共病的研究进展[J].医药前沿,2023,13(7):45-48.4.史玉玲,陈文娟.银屑病共病的现状及诊治[J].诊断学理论与实践,2023,22(3):221-229.5.胡煜顾恒陈崑.中国中重度银屑病疾病负担和未满足治疗需求的系统综述[J].中华皮肤科杂志,2023,56(10):965-972.声明：本内容为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 白闪闪合作、投稿、转载开白 | 马老师 18323856316（同微信）如需定制医药咨询服务，请扫描下方二维码咨询！ 阅读原文，是受欢迎的文章哦