Observational data have suggested no increased risk of adverse pregnancy outcomes associated with exposure to interferon-beta (IFNB) before or during pregnancy. After the emergence of these data, the European Medicines Agency approved a label change for IFNB in September 2019, stating that use of IFNB during pregnancy may be considered, if clinically needed. However, limited data on pregnancies exposed in the 2nd and 3rd trimesters were observed.
INFORM is a secondary use of data drug utilisation study (DUS) to determine late pregnancy exposure (i.e. during the 2nd and 3rd trimester) to IFNB in Finland and Sweden, which will inform whether the number of exposed pregnancies is adequate to conduct a cohort study on adverse pregnancy outcomes, with a focus on late pregnancy exposure.
The number of pregnancies will be initially reported three years after the revised label implementation (September 2019) and will include data on pregnancies from 1996 in Finland and from 2005 in Sweden up through 31 December 2022. If the number of pregnancies is deemed adequate for conducting the cohort study on adverse pregnancy outcomes, this DUS will be finalised with the drug utilisation data accrued up through 31 December 2022. If the number of pregnancies until 31 December 2022 is deemed inadequate, this study may be continued and the primary and secondary objectives may be examined five years after the revised label implementation, including pregnancies until 31 December 2024.

开始日期2024-03-20

申办/合作机构

Bayer AG

[+3]

NCT05688436

/ RecruitingN/A

Pregnancy Outcomes in Women Exposed to Diroximel Fumarate

The primary objective of the study is to estimate the prevalence of major congenital malformations (MCMs) and compare the prevalence between the diroximel fumarate (DRF) and comparator groups. The secondary objectives of the study are to estimate the incidence of spontaneous abortion (SA) and compare the incidence between the DRF and comparator groups; to estimate the incidence of preterm birth and compare the incidence between the DRF and comparator groups; to estimate the incidence of stillbirth and compare the incidence between the DRF and comparator groups and to estimate the prevalence of small for gestational age (SGA) and compare the prevalence between the DRF and comparator groups.

开始日期2021-09-24

申办/合作机构

Biogen, Inc.

NCT04079088

/ Withdrawn临床2期

A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Phase 2 Study to Evaluate the Efficacy and Safety of Oral BIIB061 as Add-On Therapy to Interferon-Beta 1 or Glatiramer Acetate Therapies in Relapsing Multiple Sclerosis

The primary objectives of the study are to evaluate the safety of BIIB061 versus placebo in participants with Relapsing Multiple Sclerosis (RMS), and to evaluate the efficacy of BIIB061 to improve disability outcome versus placebo in participants with RMS.
The secondary objectives of the study are to evaluate the effects of BIIB061 versus placebo on brain magnetic resonance imaging (MRI) markers of remyelination and axon preservation in chronic Multiple Sclerosis lesions and to evaluate the effects of BIIB061 versus placebo on additional measures of improved disability outcome.

开始日期2021-06-30

申办/合作机构

Biogen, Inc.

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100 项与聚乙二醇干扰素β-1a 相关的专利（医药）

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项与聚乙二醇干扰素β-1a 相关的文献（医药）

2025-02-01·Multiple Sclerosis and Related Disorders

Efficacy and safety of disease-modifying therapies in pediatric-onset multiple sclerosis: A systematic review of clinical trials and observational studies

Review

作者: Moćko, Paweł ; Brzostek, Tomasz ; Śladowska, Katarzyna ; Kawalec, Paweł

OBJECTIVE:

This study aimed to review the efficacy and safety profile of disease-modifying therapies (DMTs) in patients with relapsing pediatric-onset multiple sclerosis (POMS).

METHODS:

A systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Published randomized controlled trials (RCTs), nonrandomized studies with a control group, large single-arm studies, and ongoing (unpublished) studies investigating the use of approved and unapproved DMTs in POMS were included. Eligible published studies were identified in MEDLINE (via PubMed), EMBASE, and the Cochrane Library, and unpublished studies were identified in a clinical trials registry (www.

CLINICALTRIALS:

gov).

RESULTS:

A total of 13 published studies were included in the systematic review: 4 RCTs, 3 observational studies with a control group, and 6 large single-arm studies. The following DMTs for the treatment of POMS were evaluated in the included studies: interferon beta-1a, interferon beta-1b, teriflunomide, dimethyl fumarate, fingolimod, natalizumab, glatiramer acetate, and ocrelizumab. All DMTs were shown to be effective in reducing relapse rates, preventing disability progression, and reducing disease activity in MRI in patients with POMS. DMTs that are considered highly effective in adults with multiple sclerosis (natalizumab, fingolimod) were also shown to be more effective than interferon beta-1a in POMS. A total of 9 ongoing (unpublished) studies were identified, including 5 RCTs. The following drugs were evaluated: ozanimod, fingolimod, peginterferon beta-1a, ocrelizumab, ofatumumab, siponimod, alemtuzumab, and natalizumab.

CONCLUSION:

The number of DMTs approved for the treatment of POMS is limited, and some of the available DMTs are used off-label. The available evidence from published studies of varying reliability supports the efficacy of DMTs in POMS. However, well-designed, long-term RCTs in the pediatric population are needed. The results of ongoing studies may fill the existing gap in clinical evidence, possibly leading to the approval of more highly effective DMTs for patients with POMS.

2024-10-01·Multiple Sclerosis and Related Disorders

Efficacy and safety of peginterferon beta-1a compared to interferon beta-1a in relapsing remitting multiple sclerosis patients: A phase 3, randomized, non-inferiority clinical trial (PEGINTEGRITY)

Article

作者: Saeidi, Morteza ; Ghiasian, Masoud ; Baghbanian, Seyed Mohammad ; Abolfazli, Roya ; Ayromlou, Hormoz ; Ghalyanchi Langroodi, Hamidreza ; Asadollahzadeh, Elnaz ; Shaygannejad, Vahid ; Beladi Moghadam, Nahid ; Ashtari, Fereshteh ; Sabzvari, Araz ; Kafi, Hamidreza ; Azimi Saeen, Amirreza

BACKGROUND:

Multiple sclerosis (MS) is a prevalent, disabling, inflammatory, neurodegenerative disease that typically manifests during a highly productive stage of life. Interferon beta-1a was among the first approved disease-modifying therapies for MS and remains among the first-line treatment options. Pegylation of the interferon beta-1a molecule prolongs its half-life while maintaining its efficacy and safety profile. In PEGINTEGRITY study, we aimed to compare peginterferon beta-1a with interferon beta-1a in terms of efficacy and safety in relapsing-remitting multiple sclerosis (RRMS) patients.

METHODS:

This study was a randomized, active-controlled, parallel-group, multi-center Phase 3 trial conducted in Iran in participants with RRMS. Participants received 125 µg of subcutaneous peginterferon beta-1a every two weeks or 30 µg of intramuscular interferon beta-1a once a week for up to 96 weeks. The primary outcome was the non-inferiority of peginterferon beta-1a to interferon beta-1a in reducing annualized relapse rate (ARR). Other outcomes included the number of patients with 12-week confirmed disability progression, the number of new or newly-enlarging T2 hyperintense lesions, the number of gadolinium-enhancing lesions, the number of new T1 hypointense lesions, the volume of new or newly-enlarging T2 hyperintense lesions, changes in brain volume, immunogenicity, and safety assessments.

RESULTS:

A total of 168 patients who met the eligibility criteria were enrolled and assigned to two arms of the study, each consisting of 84 participants. Totally, 41 participants (24 patients in the peginterferon beta-1a group and 17 patients in the interferon beta-1a group) were withdrawn from the study. The withdrawn patients were included in the per-protocol analysis for the period of time they were in the study. In 96 weeks, in the per-protocol population, the ARR was 0.05 in the peginterferon beta-1a group versus 0.11 in the interferon beta-1a group, which does not reflect a statistically significant difference (p=0.09; 95 % CI, 0.18-1.14). Considering the upper limit of the one-sided 95 % CI of the rate ratio of peginterferon beta-1a compared to interferon beta-1a, as well as the non-inferiority margin, it can be concluded that the primary outcome was met. The results were also comparable for other efficacy and safety outcomes.

CONCLUSION:

The results demonstrate the non-inferiority of peginterferon beta-1a to interferon beta-1a with similar efficacy in 96-week ARR in RRMS patients. Both arms were also comparable in other efficacy outcomes and safety profiles with no statistically significant differences. These findings support considering peginterferon beta-1a as a safe and efficient option in patients with RRMS. This study was registered on Iranian Registry of Clinical Trials (IRCT201612306135N8) and clinicaltrials.gov (NCT05242133).

2024-04-01·Multiple Sclerosis Journal-Experimental Translational and Clinical

Safety and clinical effectiveness of peginterferon beta-1a for relapsing multiple sclerosis in a real-world setting: Final results from the Plegridy Observational Program

Article

作者: Kumar, Achint ; Belviso, Nicholas ; Nelles, Gereon ; Koster, Thijs ; Salvetti, Marco ; Castro-Borrero, Wanda ; Wray, Sibyl ; Vignos, Megan

Background:

Interferon beta-1a remains an important treatment option for multiple sclerosis, particularly when safety or tolerability concerns may outweigh the benefits of higher-efficacy disease-modifying therapies. The five-year phase 4 Plegridy Observational Program (POP) study (NCT02230969) collected data on real-world safety and effectiveness of Plegridy® (peginterferon beta-1a) treatment in patients with relapsing multiple sclerosis.

Objective:

To explore the real-world safety and effectiveness of peginterferon beta-1a in patients with relapsing multiple sclerosis, including factors influencing treatment discontinuation.

Methods:

Data were collected prospectively from patients ≥ 18 years old with relapsing multiple sclerosis for overall population analysis and for subpopulations including newly/previously diagnosed patients, age, and experience with peginterferon beta-1a. Outcome measures included annualized relapse rates, adverse events, and predictors of time to treatment discontinuation.

Results:

Mean (SD) treatment duration in the overall population ( N = 1172) was 896.0 (733.15) days. Incidence of adverse events was higher in new than experienced users (79.4% vs. 57.0%). New users were more likely than experienced users to discontinue (hazard ratio = 1.60; P < 0.0001). The adjusted annualized relapse rate was 0.09, and at the end of 5 years, 77.1% of patients were relapse-free.

Conclusions:

Peginterferon beta-1a is an effective therapy for managing relapsing multiple sclerosis. The identification of predictors of discontinuation can help inform strategies to enhance treatment persistence.

项与聚乙二醇干扰素β-1a 相关的新闻（医药）

2024-11-09

·药事纵横

6家专注于多发性硬化症治疗的biotech

声明：因水平有限，错误不可避免，或有些信息非最及时，欢迎留言指出。本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及）;本文不构成任何投资建议。多发性硬化症是中枢神经系统（CNS）的一种慢性疾病。作为一种不可预测的疾病，对人的影响不同，一些多发性硬化症患者可能只有轻微的症状，而另一些患者可能会在大脑与身体其他部位之间的交流中断时失去清晰地看、写、说或走路的能力。以下是六家专注于多发性硬化症的生物技术公司，几家公司和研究人员试图通过不同的方法来治疗多发性硬化症，比如BTK抑制剂、CAR-T疗法、双特异性抗体，甚至干细胞疗法。 Biogen 主要多发性硬化候选药物：BIIB091 Biogen以其在神经科学领域的开创性工作而闻名。40多年来，它一直在发现和开发中枢神经系统疾病的治疗方法，包括多发性硬化、肌萎缩侧索硬化（ALS）、阿尔茨海默病、抑郁症、狼疮和脊髓性肌萎缩（SMA）的治疗方法。至于多发性硬化症，该公司已经有几种已获批准的治疗方法，包括Avonex、Plegridy和Vumerity，这些药物都用于治疗多发性硬化症的复发。此外，在其现有的研发过程中，百健正致力于开发下一代伯顿酪氨酸激酶（BTK）抑制剂，称为BIIB091，用于复发性多发性硬化成人患者。目前正处于开发的第二阶段。 BTK是一种非受体酪氨酸激酶，可调节被认为与多发性硬化发病机制有关的B细胞和髓样细胞的发育和信号传导。BIIB091除对B细胞产生作用外，还对髓系细胞中的BTK产生可逆性抑制作用，因此预计BIIB091与仅B细胞疗法相比具有更多的临床益处，并且可以解决共价BTK抑制剂中观察到的耐药性。 Immunic Therapeutics 主要多发性硬化候选药物：Vidofludimus calcium immunictherapeutics正致力于慢性炎症性和自身免疫性疾病的小分子疗法的开发。其主要候选药物是vidofludimus calcium（IMU-838），目前正在开发用于治疗多发性硬化。 IMU-838通过有效激活称为核受体相关1 （Nurr1）的神经保护转录因子发挥作用，Nurr1与直接的神经保护特性相关，并可能增强患者的潜在获益。IMU-838还抑制二氢乳清酸脱氢酶（DHODH），后者是过度活跃的免疫细胞和病毒感染细胞代谢的关键酶。这一双重作用不仅针对炎症和抗病毒过程，而且还解决了多发性硬化潜在的神经退行性方面，使其从现有疗法中脱颖而出，现有疗法虽然能够控制多发性硬化的复发，但不能阻止患者的残疾随着时间的推移而恶化。数项正在进行的多发性硬化试验正在对IMU-838进行测试，包括复发性多发性硬化的两项3期试验和进展性多发性硬化的支持性2期试验。2023年10月，Immunic报告了2期试验的阳性中期数据，因为有生物标志物证据表明，IMU-838的活性超出了之前观察到的抗炎作用。最终，这进一步加强了它的神经保护潜力。此外，在2024年1月，Immunic宣布了高达2.4亿美元的私募。 Kyverna Therapeutics 主要多发性硬化候选药物：KVY-101 Kyverna Therapeutics公司正致力于开发针对b细胞驱动的自身免疫性疾病患者的细胞疗法。这家多发性硬化症公司拥有靶向CD19的自体和异体CAR化合物，该分子在B淋巴细胞的发育、激活和分化中起着重要作用，旨在减少细胞因子释放，消耗B细胞，提高临床耐受性。其主要候选药物KYV-101目前正在一项2期试验中评估用于治疗多发性硬化以及重症肌无力。今年1月，它被美国食品药品监督管理局（FDA）授予快速通道认定，用于治疗难治性进行性多发性硬化患者。此外，Kyverna在2024年2月通过首次公开发行（IPO）获得了.66亿美元的总收益。 Progentos Therapeutics 几个月前，Progentos Therapeutics才成立，获得了6500万美元的A轮融资，用于推进多发性硬化和其他退行性疾病的治疗。在多发性硬化症等疾病中，残疾是由支持轴突功能和生存的脱髓鞘（即髓鞘受损）引起。在这里，免疫系统攻击髓鞘，导致炎症和神经细胞功能受损。正因为如此，Progentos正在开发一种新型小分子，旨在诱导多发性硬化影响的轴突的髓鞘再生。该公司从麻省理工学院（MIT）的子公司Frequency Therapeutics收购了多发性硬化症项目，后者于2023年与RNA编辑公司Korro Bio进行了反向合并。根据Progentos的说法，当涉及到产生和维持髓磷脂的细胞时，它的分子在动物模型中似乎比以前的方法表现更好。从多发性硬化症公司最近的A轮融资中获得的资金将使其能够通过人体概念验证研究来推进其多发性硬化症项目，并扩大其在其他退行性疾病中的研发渠道。 TG Therapeutics 主要多发性硬化候选药物：ublituximab TG Therapeutics专注于利用b细胞生物学的科学进步为患者开发新的治疗方法，特别专注于开发自身免疫性疾病的治疗方法。该公司于2022年12月宣布，FDA已批准其药物BRIUMVI （ublituximab）用于治疗复发型多发性硬化症患者，包括临床孤立综合征，复发缓解性疾病和活动性继发进行性疾病。此外，在2024年9月，TG Therapeutics报告说，经过5年的BRIUMVI治疗，92%的复发性多发性硬化症患者无残疾进展。 Ublituximab是一种单克隆抗体，靶向表达cd20的b细胞上的一个独特表位。当药物与b细胞结合时，会触发一系列免疫反应，包括抗体依赖性细胞毒性[ADCC]和补体依赖性细胞毒性[CDC]，最终导致细胞破坏。此外，阿妥昔单抗被设计为缺乏抗体上正常表达的某些糖分子，因为去除这些糖分子（称为糖工程的过程）已被证明可增强阿妥昔单抗的效力，特别是在ADCC活性方面。作为与Precision BioSciences合作的一部分，TG Therapeutics还在开发一种名为azer-cel的同种异体CAR-T疗法，用于治疗进展型多发性硬化症。Precision BioSciences发现并授权给TG Therapeutics的这一候选药物最近获得了试验性新药（IND）许可，有望于今年晚些时候开始临床试验。 Zenas BioPharma 主要多发性硬化候选药物：Obexelimab Zenas BioPharma专注于基于免疫学的疗法，目前正致力于开发其主要候选药物obexelimab，用于治疗各种免疫学和炎症疾病，包括多发性硬化。 Obexelimab是一种双功能单克隆抗体，旨在通过与广泛存在于B细胞谱系中的蛋白CD19和FcγRIIb结合来耗竭B细胞。根据该公司的说法，这些靶点的共同参与导致了B细胞活性的抑制。 Zenas BioPharma目前正在一项2期试验中纳入患者，以评估obexelimab治疗复发性多发性硬化患者的疗效和安全性。该公司最近也筹集了可观的资金。2024年5月，该公司宣布在C轮融资中获得2亿美元，9月还宣布了2.25亿美元的IPO。这两轮融资的收益将帮助该公司进一步推进obexelimab的研发。参考资料：各公司官网 -END- 2025CMC-CHINA药博会 • 展位火热预定中！

临床2期细胞疗法免疫疗法临床1期临床3期

2024-10-31

·Insight数据库

渤健 2024Q3：仑卡奈单抗卖了 6700 万美元，环比增长 66%

10 月 30 日，渤健发布 2024Q3 业绩，前三季度总营收 72.21 亿美元（-3%），其中产品收入 53.81 亿美元；第三季度营收 24.66 亿美元（-2.5%）。其中，用于阿尔兹海默病的 LEQEMBI（仑卡奈单抗）第三季度全球销售额约 6700 万美元，较上一季度增长 66%，其中美国市场销售额约 3900 万美元。截图来源：渤健财报仑卡奈单抗是全球首个获 FDA 完全批准的 AD 新药，今年三季度取得的进展如下： • 2024 年 7 月，卫材公布了 LEQEMBI 的 CLARITY AD 研究开放标签扩展的新临床数据，表明连续三年的 LEQEMBI 治疗减少了临床衰退，对早期阿尔茨海默病患者有临床意义的益处。 • 2024 年 6 月，FDA 接受了审查 LEQEMBI 每月静脉维持剂量治疗早期阿尔茨海默病的补充 BLA，PDUFA 行动日期定为 2025 年 1 月 25 日。 • 2024 年 5 月，在获得 FDA 快速通道资格后，卫材开始向 FDA 滚动提交 LEQEMBI 皮下自动注射的 BLA，用于每周维持剂量。多发性硬化症领域第三季度实现营收 10.54 亿美元同比 -9%。（主要产品包括 TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI, 和 FAMPYRA）罕见病领域实现营收 4.95 亿美元，同比+10%。（主要产品包括SPINRAZA, SKYCLARYS 和 QALSODY）产后抑郁药物 ZURZUVAE（舒拉诺龙）第三季度收入约为 2200 万美元。截图来源：渤健财报渤健提高了 2024 年全年财务指引：截图来源：渤健财报维持 2024 年全年总收入较 2023 年全年下降个位数百分比的预期，核心药品收入预计与 2023 年全年大致持平；与 2023 年全年相比，目前预计营业收入将以较高的百分比增长，营业利润率将保持中等个位数的增长。重点产品前三季度销售额：截图来源：渤健财报封面来源：企业 Logo 免责声明：本文仅作信息分享，不代表 Insight 立场和观点，也不作治疗方案推荐和介绍。如有需求，请咨询和联系正规医疗机构。编辑：vvy PR 稿对接：微信 insightxb 投稿：微信 insightxb；邮箱 insight@dxy.cn 多样化功能、可溯源数据…… Insight 数据库网页版等你体验点击阅读原文，立刻解锁！

财报

2024-04-04

·PRNewswire

Cadenza Bio, Inc. Appoints Michael A. Panzara, MD, MPH, to its Board of Directors

OKLAHOMA CITY, April 4, 2024 /PRNewswire/ -- Cadenza Bio, Inc., a pioneering preclinical biotechnology company dedicated to developing innovative small-molecule drugs for the treatment of multiple sclerosis (MS) and other demyelinating and inflammatory diseases, proudly announces the appointment of Michael A. Panzara, MD, MPH, to its esteemed board of directors. Dr. Panzara brings over 22 years of invaluable biopharmaceutical experience to Cadenza Bio. He currently serves as chief medical officer at Neurvati Neurosciences, a neuroscience-focused biotechnology company working to advance the development of clinical-stage product candidates for neurological and neuropsychiatric disorders. Prior to his role at Neurvati, Dr. Panzara held key leadership positions at Wave Life Sciences, Sanofi, Genzyme, and Biogen, showcasing his deep understanding of neurological disorders and drug development. He also serves on the board of directors of Athira Pharma, Inc., a neurology-focused clinical-stage biopharmaceutical company. Over his career, Dr. Panzara oversaw development activities and global regulatory approvals for several MS drugs. He served as the head of the Multiple Sclerosis, Neurology, and Ophthalmology Therapeutic Area for Global Development at Sanofi Genzyme, where he oversaw global regulatory approvals of LEMTRADA® (alemtuzumab) and AUBAGIO® (teriflunomide) and was responsible for development strategy and oversight within these therapeutic areas. During his time at Biogen, he served as global clinical lead for the development of TYSABRI® (natalizumab) for MS and managed clinical development activities for all late-stage MS products including AVONEX® (interferon beta-1a), PLEGRIDY® (PEG-interferon beta-1a), and TECFIDERA® (dimethylfumarate). "We are delighted to welcome Dr. Panzara to our board of directors," said Dr. Carol Curtis, chief executive officer of Cadenza Bio. "His extensive experience in developing therapies for MS and other neurological disorders aligns perfectly with our mission at Cadenza Bio. Dr. Panzara's strategic insights and deep understanding of the industry will be invaluable as we continue to advance our innovative drug pipeline and work towards bringing transformative treatments to patients in need." Dr. Panzara received his undergraduate degree in biology from the University of Pennsylvania and his medical degree from Stanford University School of Medicine. He completed his neurology training at Massachusetts General Hospital and received postdoctoral training in immunology and rheumatology at Brigham and Women's Hospital. Additionally, Dr. Panzara earned his master of public health degree from the Harvard School of Public Health. With Dr. Panzara joining the board of directors, Cadenza Bio is in a stronger position to achieve its goal of developing groundbreaking therapies for MS and other demyelinating and inflammatory diseases. "I look forward to joining the board of directors at Cadenza Bio at such an exciting time in the growth of the company," said Dr. Panzara. "Their approach in developing innovative dual-action therapeutic agents with neuroprotective and immunomodulatory effects has great potential to significantly expand our ability to address the unmet needs that remain for many MS patients." For more information about Cadenza Bio and its groundbreaking research, please visit . About Cadenza Bio, Inc. Cadenza Bio, Inc. is a preclinical biotechnology company focused on developing innovative small-molecule drugs for the treatment of demyelinating and inflammatory diseases. The company's mission is to break the cycle of disease and transform lives by developing therapies that not only alleviate symptoms but also halt progression, promote repair, and restore quality of life for patients. Cadenza Bio's MS drug pipeline, emerging from a collaboration between leading researchers, demonstrates promising preclinical results and offers hope for patients suffering from these debilitating conditions. SOURCE Cadenza Bio, Inc.

高管变更

100 项与聚乙二醇干扰素β-1a 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10483	聚乙二醇干扰素β-1a	L03AB13	DB09122

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
多发性硬化症	美国	Biogen, Inc.	2014-08-15
复发-缓解型多发性硬化	欧盟	Biogen Netherlands BV	2014-07-18
复发-缓解型多发性硬化	冰岛	Biogen Netherlands BV	2014-07-18
复发-缓解型多发性硬化	列支敦士登	Biogen Netherlands BV	2014-07-18
复发-缓解型多发性硬化	挪威	Biogen Netherlands BV	2014-07-18

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
流感样症状	临床3期	美国	Biogen, Inc.	2013-11-01
复发性多发性硬化	临床3期	美国	Biogen, Inc.	2009-06-01
复发性多发性硬化	临床3期	比利时	Biogen, Inc.	2009-06-01
复发性多发性硬化	临床3期	保加利亚	Biogen, Inc.	2009-06-01
复发性多发性硬化	临床3期	加拿大	Biogen, Inc.	2009-06-01
复发性多发性硬化	临床3期	智利	Biogen, Inc.	2009-06-01
复发性多发性硬化	临床3期	哥伦比亚	Biogen, Inc.	2009-06-01
复发性多发性硬化	临床3期	克罗地亚	Biogen, Inc.	2009-06-01
复发性多发性硬化	临床3期	捷克	Biogen, Inc.	2009-06-01
复发性多发性硬化	临床3期	爱沙尼亚	Biogen, Inc.	2009-06-01

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临床结果

适应症

分期

评价

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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


German Multiple Sclerosis and Pregnancy Registry (ECTRIMS2023)	N/A	多发性硬化症	247	Interferon beta-1a	襯壓範選淵繭鹹餘積獵(壓網齋膚積選選廠積選) = comparable between exposed children and controls during the observation period 餘艱衊範觸襯鏇鹽積鬱 (餘顧淵鑰襯窪憲鹽網醖 ) 更多	积极	2023-09-30
NCT03870763 (CTgov)	临床3期	复发-缓解型多发性硬化	11	Dimethyl Fumarate (Dimethyl Fumarate 240 mg)	選糧鹽觸鏇遞鹹鏇鹹觸(構網襯壓壓願鏇淵糧窪) = 衊餘襯鑰獵構鹽壓糧廠壓鬱繭衊願觸築構鏇廠 (餘艱醖齋鹹壓顧糧餘築, 顧鬱積簾網觸製淵獵遞 ~ 築遞鏇積鬱構製願積鏇) 更多	-	2023-05-16
				Peginterferon Beta-1a (Peginterferon Beta-1a 125 µg)	選糧鹽觸鏇遞鹹鏇鹹觸(構網襯壓壓願鏇淵糧窪) = 廠獵壓鏇遞蓋構齋艱鹽壓鬱繭衊願觸築構鏇廠 (餘艱醖齋鹹壓顧糧餘築, 遞餘憲積鏇築鏇遞範構 ~ 鏇衊窪築鑰醖願鹹鏇襯) 更多
German Multiple Sclerosis and Pregnancy Registry (ECTRIMS2022)	N/A	多发性硬化症	70	Interferon-beta 1a exposure during pregnancy	構鬱蓋淵製範襯鹹鹹憲(壓鏇繭淵積顧製網築蓋) = 鹽艱製襯餘築壓齋衊鑰構積繭顧廠構繭壓築鹽 (範膚艱範遞鹹選淵選製 )	积极	2022-10-12
IMSE 6 (ECTRIMS2021)	N/A	-	393	Peginterferon beta-1a	齋艱蓋鹽鹹鑰積淵糧網(構夢願築獵築構築構積) = General disorders and administration site were also the most common for non-serious AEs (68%) 網襯衊窪顧醖鏇獵鑰鏇 (積鬱鑰選鏇鹽窪觸齋糧 ) 更多	积极	2021-10-12
Plegridy Observational Program (ECTRIMS2021)	N/A	复发性多发性硬化	1,208	Peginterferon beta-1a	衊蓋積夢鹽選蓋積鏇艱(鑰繭網窪觸築廠遞衊築) = 廠鏇顧築簾窪鑰餘觸願觸築選遞選鬱廠築壓鹽 (鏇夢齋構鹽積製艱淵窪 ) 更多	积极	2021-10-12
				Placebo	衊蓋積夢鹽選蓋積鏇艱(鑰繭網窪觸築廠遞衊築) = 夢夢積糧獵蓋鏇壓獵衊觸築選遞選鬱廠築壓鹽 (鏇夢齋構鹽積製艱淵窪 ) 更多
ECTRIMS2020	N/A	-	-	Peginterferon beta-1a	廠獵醖構廠顧襯餘範簾(積觸選蓋製鏇遞鹹糧淵): ARR ratio = 1.18 (95% CI, 0.72 ~ 1.94), P-Value = 0.5047 更多	-	2020-12-07
				Non-pegylated interferons
ECTRIMS2020	N/A	多发性硬化症	2,479	Peginterferon beta-1a	鬱襯襯遞膚遞積構衊顧(網範襯齋鬱鏇範廠壓簾) = 網鑰鹹廠衊簾憲觸積餘夢選夢製顧艱鏇蓋鹽蓋 (範蓋鑰鑰觸齋夢積觸醖 ) 更多	-	2020-12-07
				Intramuscular interferon beta-1a	夢憲淵獵醖選積憲襯鬱(壓簾糧蓋夢鹹選鏇鹽構) = 憲鹽網壓廠膚觸醖夢獵積製窪齋顧觸遞簾窪繭 (憲鑰艱獵憲壓鹹衊憲選 )
NARCOMS (ECTRIMS2020)	N/A	复发性多发性硬化	-	Intramuscular interferon beta-1a	壓餘齋膚鬱襯鑰窪鏇餘(餘鑰簾簾積鹹餘願築觸) = 遞構鹽觸遞餘鏇製簾艱蓋鏇築積壓鹽餘窪鬱顧 (選範積繭夢製構餘糧襯 ) 更多	积极	2020-12-07
				Peginterferon beta-1a	壓餘齋膚鬱襯鑰窪鏇餘(餘鑰簾簾積鹹餘願築觸) = 築齋齋齋夢廠廠製構醖蓋鏇築積壓鹽餘窪鬱顧 (選範積繭夢製構餘糧襯 ) 更多
IMSE 6 (ECTRIMS2020)	N/A	-	364	Peginterferon beta-1a	鬱積遞壓製範築顧衊廠(鏇積遞憲鏇構獵鹽網膚) = A total number of 18 adverse events (6 serious) were reported to Swedish Medical Product Agency. 糧夢膚積膚鹽遞遞艱憲 (積觸齋艱壓窪獵遞築齋 )	-	2020-12-07
PLEGRIDY Observational Program (ECTRIMS2020)	临床4期	复发性多发性硬化	1,208	peginterferon beta-1a (Newly diagnosed patients)	夢蓋簾鑰製艱獵鹹鬱糧(願製鏇積壓蓋簾簾鹹鏇) = 觸壓遞艱築廠襯蓋餘衊簾鬱願繭築製淵糧醖願 (鬱廠憲積齋艱願鹹鏇廠 ) 更多	-	2020-12-07
				peginterferon beta-1a (Non-newly diagnosed patients)	夢蓋簾鑰製艱獵鹹鬱糧(願製鏇積壓蓋簾簾鹹鏇) = 築艱鏇醖窪選艱鹹鏇窪簾鬱願繭築製淵糧醖願 (鬱廠憲積齋艱願鹹鏇廠 ) 更多