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2024-09-02

申办/合作机构

Bayer AG

[+3]

NCT05658497 / RecruitingN/A

Vumerity (Diroximel Fumarate) Prospective MS Pregnancy Exposure Registry

The primary objectives of the study are to estimate the risk of major congenital malformations (MCMs) in infants born to women with multiple sclerosis (MS) who were exposed to diroximel fumarate (DRF) at any time from 2 weeks after the first day of their last menstrual period (LMP) up through the first trimester of pregnancy and to comparatively evaluate pregnancy outcomes with MCMs in women with MS who were exposed to DRF at any time from 2 weeks after the first day of their LMP through the first trimester of pregnancy with the following: i) women with MS who were unexposed to disease modifying therapies (DMTs) and, ii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries).
The secondary objective of the study is to evaluate pregnancy outcomes in women with DRF exposure at any time from 2 weeks after the first day of their LMP through the end of pregnancy compared with the following: i) women with MS who were unexposed to DMTs, ii) women with dimethyl fumarate (DMF) exposure, iii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries), and iv) women without MS (e.g., women from external, general population comparators).

开始日期2023-10-27

申办/合作机构

Biogen, Inc.

PACTR202205508723236 / Suspended临床3期IIT

A multi-centre, placebo-controlled studyof interferon beta-1a in high risk COVID-19 outpatients (InterCoV)

开始日期2022-05-15

申办/合作机构-

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项与干扰素β-1a(Biogen, Inc.) 相关的文献（医药）

2024-02-13·Neurology

Adverse Events Associated With Disease-Modifying Drugs for Multiple Sclerosis

Article

作者: Fisk, John D ; Zhu, Feng ; Ekuma, Okechukwu ; Yao, Shenzhen ; Marrie, Ruth Ann ; Lu, Xinya ; Zhao, Yinshan ; Ng, Huah Shin ; Tremlett, Helen ; Evans, Charity

BACKGROUND AND OBJECTIVES:

It is not possible to fully establish the safety of a disease-modifying drug (DMD) for multiple sclerosis (MS) from randomized controlled trials as only very common adverse events occurring over the short-term can be captured, and the quality of reporting has been variable. We examined the relationship between the DMDs for MS and potential adverse events in a multiregion population-based study.

METHODS:

We identified people with MS using linked administrative health data from 4 Canadian provinces. MS cases were followed from the most recent of first MS or related demyelinating disease event on January 1, 1996, until the earliest of emigration, death, or December 31, 2017. DMD exposure primarily comprised β-interferon, glatiramer acetate, natalizumab, fingolimod, dimethyl fumarate, teriflunomide, and alemtuzumab. We examined associations between DMD exposure and infection-related hospitalizations and physician visits using recurrent events proportional means models and between DMD exposure and 15 broad categories of incident adverse events using stratified multivariate Cox proportional hazard models.

RESULTS:

We identified 35,894 people with MS. While virtually all DMDs were associated with a 42%-61% lower risk of infection-related hospitalizations, there was a modest increase in infection-related physician visits by 10%-33% for select DMDs. For incident adverse events, most elevated risks involved a second-generation DMD, with alemtuzumab's hazard of thyroid disorders being 19.42 (95% CI 9.29-36.51), hypertension 4.96 (95% CI 1.78-13.84), and cardiovascular disease 3.72 (95% CI 2.12-6.53). Natalizumab's highest risk was for cardiovascular disease (adjusted hazard ratio [aHR] 1.61; 95% CI 1.24-2.10). For the oral DMDs, fingolimod was associated with higher hazards of cerebrovascular (aHR 2.04; 95% CI 1.27-3.30) and ischemic heart diseases (aHR 1.64; 95% CI 1.10-2.44) and hypertension (aHR 1.73; 95% CI 1.30-2.31); teriflunomide with higher hazards of thyroid disorders (aHR 2.30; 95% CI 1.11-4.74), chronic liver disease (aHR 1.94; 95% CI 1.19-3.18), hypertension (aHR 1.76; 95% CI 1.32-2.37), and hyperlipidemia (aHR 1.61; 95% CI 1.07-2.44); and from complementary analyses (in 1 province), dimethyl fumarate with acute liver injury (aHR 6.55; 95% CI 1.96-21.87).

DISCUSSION:

Our study provides an extensive safety profile of several different DMDs used to treat MS in the real-world setting. Our findings not only complement those observed in short-term clinical trials but also provide new insights that help inform the risk-benefit profile of the DMDs used to treat MS in clinical practice. The results of this study highlight the continued need for long-term, independent safety studies of the DMDs used to treat MS.

CLASSIFICATION OF EVIDENCE:

This study provides Class III evidence that for patients with MS, while DMD exposure reduces the risk of infection-related hospitalizations, there are increased risks of infection-related physician visits and incident adverse events for select DMDs.

2024-02-01·Journal of neurology

Ocrelizumab exposure in relapsing–remitting multiple sclerosis: 10-year analysis of the phase 2 randomized clinical trial and its extension

Article

作者: Hauser, Stephen L ; Li, David K B ; Wang, Qing ; Schneble, Hans-Martin ; Traboulsee, Anthony ; Barkhof, Frederik ; Kappos, Ludwig ; Montalban, Xavier ; Leppert, David ; Baldinotti, Anna ; Sauter, Annette ; Koendgen, Harold ; Bar-Or, Amit

Abstract:

Open-label extension (OLE) studies help inform long-term safety and efficacy of disease-modifying therapies in multiple sclerosis (MS). We report exploratory analyses from a phase 2 trial on the longest follow-up to date of ocrelizumab-treated patients with relapsing–remitting MS (RRMS). The primary treatment period (PTP) comprised four 24-week treatment cycles; participants were randomized to double-blind ocrelizumab (2000 mg or 600 mg), placebo, or interferon β-1a (open label) for one cycle, then dose-blinded ocrelizumab 1000 mg or 600 mg for the remaining cycles. The PTP was followed by consecutive assessed and unassessed treatment-free periods (TFPs) and then the OLE (ocrelizumab 600 mg every 24 weeks). Safety and efficacy were prospectively assessed. Of 220 participants randomized, 183 (84%) completed the PTP. After the TFP, 103 entered OLE (median OLE ocrelizumab exposure 6.5 years). Most common adverse events across all periods were infusion-related reactions. MRI activity, annualized relapse rate, and confirmed disability progression (CDP) rates remained low throughout. During the assessed TFP, there was a trend toward less and later B-cell repletion, and later CDP, for patients randomized to ocrelizumab; MRI activity was observed in 16.3% of patients, the earliest 24 weeks after the last ocrelizumab dose. This is the longest follow-up of ocrelizumab-treated patients with RRMS, with no new safety signals emerging during an observation period from 2008 to 2020. Results reinforce the sustained efficacy of long-term ocrelizumab. Reduced disease activity was maintained following interruption of 6-month dosing cycles, with no evidence of rebound.

2024-01-01·Multiple sclerosis (Houndmills, Basingstoke, England)

Disease progression in the first 5 years of treatment in multiple sclerosis: Predictive value of early brain and lesion volume changes

Article

作者: Brouwer, Iman ; De Stefano, Nicola ; Barkhof, Frederik ; Mattiesing, Rozemarijn M ; Battaglini, Marco ; Gentile, Giordano ; Uitdehaag, Bernard Mj ; Vrenken, Hugo ; van Schijndel, Ronald A ; Strijbis, Eva Mm ; Schoonheim, Menno M ; Kramer, Eline

Background::

Whether the degree of inflammation (and its resolution) and neurodegeneration after treatment initiation predicts disease progression in multiple sclerosis (MS) remains unclear.

Objectives::

To assess the predictive value of magnetic resonance imaging (MRI)-derived brain and lesion volume (LV) changes in years 1 and 2 of treatment for disease progression.

Methods::

Patients receiving early interferon beta-1a treatment in REFLEX/REFLEXION ( N = 262) were included. Predictive regression models included new/enlarging LV (positive activity), disappearing/shrinking LV (negative activity), and global/central atrophy during years 1 and 2.

Results::

Faster global atrophy and/or pseudo-atrophy and positive lesion activity in years 1 and 2 related to an increased probability and faster conversion to clinically definite multiple sclerosis (CDMS). Negative lesion activity in year 1 and slower central atrophy in year 2 were predictive of confirmed disability progression (9-Hole Peg Test). Positive lesion activity in year 2 was predictive of faster global atrophy, while positive lesion activity in years 1 and 2 was predictive of faster central atrophy.

Conclusions::

A higher degree of global atrophy and/or pseudo-atrophy in year 1 was predictive of CDMS. Positive lesion activity in any year was related to CDMS and neurodegeneration. Disability was related to negative lesion activity in year 1 and slower central atrophy in year 2.

项与干扰素β-1a(Biogen, Inc.) 相关的新闻（医药）

2024-06-03

·BioSpace

Opinion: Annexon Tackles Guillain-Barre, Other Inflammatory Diseases with Novel Antibody

Pictured: A volcano erupting of damaged and inflamed nerves/ Nicole Bean for BioSpace This quarter, Annexon Biosciences expects to release Phase III trial results from its flagship program for Guillain-Barre syndrome. At the same time, the company is looking beyond GBS and investigating the possibility of fighting other inflammation-driven diseases with the antibody, ANX005. Historically, GBS has been difficult to treat and understand due to a relative lack of understanding around the cause of the disease. With causative associations ranging from viral infections to surgeries, GBS is a rare autoimmune disease affecting approximately 12,000 people in the U.S. and Europe each year. It can debilitate patients by paralyzing peripheral nerves in the limbs. There is currently no curative or long-term treatment for GBS, although intravenous immunoglobulin (IVIg, available as a generic from multiple companies) and plasmapheresis are used for acute bouts of the disease. As a pooled antibody from human blood sources, IVIg does not lead to better outcomes in subsequent administrations for GBS after the first dose due to poor prognosis, a 2021 randomized controlled study found. The study found that compared with placebo, patients who received a second IVIg dose had more serious adverse events such as thromboembolic events. By contrast, plasmapheresis is a procedure that uses a machine to separate plasma from blood cells, then replaces the patient’s plasma before returning the blood to the body. In doing so, plasmapheresis removes antibodies in the plasma, easing the inflammation characteristic of GBS. But the procedure requires access to a central line via catheters and carries a risk of bleeding and infections. ANX005’s mechanism is different: it inhibits a protein complex called C1q that is part of the classical complement pathway, which is in turn a component of the innate immune system. ANX005 thus targets the classical complement pathway upstream while—unlike IVIg—leaving the lectin pathway and the alternative complement pathway intact. In other words, patients treated with ANX005 will still be able to activate C3 via the lectin pathway and the alternative complement pathway, but not the classical complement pathway. This mechanism likely leads to less immunosuppression than does IVIg, enabling the body to continue defending itself against pathogens. In Phase Ib trials, ANX005 was administered along with IVIg in an open-label treatment arm to GBS patients. But in Phase III trials, Annexon is betting on comparing two different ANX005 doses compared to placebo. As this trial’s primary endpoints measure the GBS Disability Score at eight weeks and look at the number of patients with adverse effects for six months, there is much at stake in terms of safety and efficacy. By targeting GBS from a new angle, ANX005 is offering hope in a therapeutic area where corticosteroids and interferon-beta 1a have failed in the past. Beyond GBS While Annexon continues to assemble data on its Phase III GBS trial for upcoming release, it is also moving toward testing C1q inhibition in other inflammatory diseases, and these trials provide additional information about its safety profile. Huntington’s disease, a progressive movement disorder, is also driven by the activation of the classical complement pathway. Based on Phase IIa safety data from its Huntington’s disease trial with ANX005, ANX005’s adverse effect pro limited to mainly infusion-site reactions that appear only upon the first dose, making it safer than IVIg for these patients. By contrast, with various side effects that appear even with the first dose such as chills, fever, flushing, flu-like muscle pains or joint pains, fatigue, nausea, vomiting, and rash, IVIg is only used when necessary to boost immune responses due to systemic adverse effects. With ANX005 also being investigated for use in amyotrophic lateral sclerosis (ALS), where the drugmaker aims to reduce disease progression, there are certainly exciting developments ahead for Annexon in the coming months. Jia Jie Chen writes analyses focusing on drug development in the biotech and pharma industries for BioSpace. He has a doctorate degree in pharmacy and experiences ranging from biotech equity research to business intelligence analysis. Follow him on LinkedIn.

临床结果临床2期临床3期

2024-05-04

·同写意

渤健并购“静悄悄”

同写意20岁庆！第五届全球生物医药前沿技术大会报名开启！“意”同创新，穿越周期。7月中旬，苏州金鸡湖畔，让我们与“新药写意人”一起为中国医药创新“同写意”！医药并购市场正在复苏，但那些希望渤健今年再进行一笔华丽交易的投资者，可能要失望了。近期，在第一季度财报的会议上，渤健CEO Chris Viehbacher透露，至少2024年度，他不打算进行任何大规模的并购交易。有意思的是，2022年底掌舵渤健前，Viehbacher曾在赛诺菲推动70项并购，最大一笔豪掷201亿美元拿下健赞，被人称为“并购先生”。Viehbacher加盟渤健之初，也一直扬言支持并购，还在上任几个月后表示：“渤健并不一定将收购视为其增长战略的一部分。但如果不想做交易，雇佣我没有什么意义。”半年后，Viehbacher用与Reata Pharmaceuticals的交易“践行”了自己的立场。这笔溢价59%，总金额达到73亿美元的交易是渤健史上金额最大的一笔，获得了目前来看可圈可点的产品。就在大家仍翘首以盼，期待这位CEO再次操办一笔时，他亲自“下场”，按下暂停。“如果真的有什么特别的东西出现，我们会考虑。但就目前的情况而言，渤健今年不会考虑在收购方面做任何事情，至少不是大规模。”Viehbacher给外界泼了一盆冷水。不进行大规模的原因有很多，产品增长乏力、转型需要等，但渤健表示绝不是因为“囊中羞涩”无法做大笔交易。截至3月31日，该公司拥有近11亿美元现金和现金等价物，税前、利息和折旧前收入约为30亿美元。事实上，自本世纪初斥资数十亿美元收购Idec以来，渤健一直避免进行大规模收购活动，除了收购Reata之外，最大的一笔还是2019年以8亿美元收购Nightstar Therapeutics。1新官上任“一把火”Viehbacher加入渤健的时候，正值后者的“至暗时刻”。曾经的明星产品——治疗多发性硬化症（MS）的Avonex和名为Spinraza的脊髓性肌萎缩疗法，均因为竞品的出现而逐渐被挤压市场份额。与此同时，近20年来的首款AD新药Aduhelm算不上体面地完成了谢幕。值得庆幸的一点是，同属于Aβ单抗的Leqembi在AD赛道闯出一片天地。2024年第一季度，Leqembi的市场收入环比增长了近3倍，创造了1900万美元的收入。渤健透露，使用AD疗法的新患者逐月大幅增加。过去一年左右的时间里，渤健明确指出，罕见病和自免疾病是值得投资的领域。出于对上述战略的回应，去年7月，渤健完成了与Reata的交易，获得了一款first-in-class的Nrf2激动剂Skyclarys。该产品于2023年3月获得FDA批准，用于治疗一种单基因遗传罕见病——弗里德赖希氏共济失调症（FA）。FA通常在儿童或青少年时期开始发病，患者会逐渐出现步态不稳，运动协调受损，肌肉无力和麻痹，出现视力、听力以及心脏问题等。这笔“史上之最”的并购，可以说几乎倾尽了渤健所有的现金储备。就在宣布收购的三天前，渤健发布2023半年报：营收49.19亿美元，同比下降4%，净利润下滑23%。目前来看，这笔交易是值得的。自1997年发现FA基因以来，Skyclarys是第一个对这些患者显示出临床益处的治疗方法，可以减缓疾病进展。今年前三个月，Skyclarys的收入总计7800万美元，总体上超出了华尔街分析师的预期，已经被渤健列为近期的增长动力。有分析师预计，到2030年，该药的美国销售潜力将达到4亿美元。渤健之外，对Nrf2激动剂进行布局的MNC还有拜耳、阿斯利康等，它们也是通过交易获得了相应的在研产品。目前，Nrf2激活剂主要分为两种，即亲电性Nrf2激活剂和直接Nrf2激活剂。亲电性激活剂具有副作用大，特异性差，存在脱靶效应等不足，因而只能用于罕见病治疗。而直接Nrf2激活剂尚处于实验室研发阶段。据弗若斯特沙利文数据显示，全球罕见病药物的市场规模预计将从2020年的1351亿美元增至2030年的3833亿美元，复合年增长率为11%。仅有5%罕见病存在有效治疗方法。虽是罕见病药物，后续蓝海很是可观。只不过，Viehbacher不打算快速复制这套交易方法论了。2巨头的精打细算作为一家深耕神经系统疾病领域40余年的制药企业，渤健过往辉煌几乎都是依靠MS系列产品支撑，最高峰时占比超过80%。不过2019年开始，渤健MS产品销售额就出现下滑势头。2023年，渤健全年营收98.36亿美元，同比下降2%，但MS药物仍然占据营收的半壁江山（47%），共卖出46.62亿美元，同比下降14%。MNC几乎都用“血泪”证明，单一的产品结构没有未来。渤健收购而得的Nrf2激动剂除了针对FA适应症外，还可以改善细胞线粒体的功能，而这是对抗AD、肌萎缩侧索硬化症等其他神经系统疾病的重要因素，这或许也是渤健看中这款产品的原因之一。但显然，这还远不能达到渤健想要多元化发展的想法。“神经科学的现实是，这是一个高风险领域。我们并不总是了解潜在的疾病生物学，疾病进展缓慢，导致了一些非常漫长和昂贵的试验，”Viehbacher在财报会议上告诉投资者，“虽然我们仍致力于神经科学，但对于我们这种规模的公司来说，这还不够多元化。”Viehbacher强调，渤健需要将其研究工作扩展到大脑和神经系统药物之外。根据他的说法，渤健在研究、开发和销售Spinraza和一系列多发性硬化症药物方面的经验，使其“在罕见疾病和向免疫学领域扩张方面具有合理性”。但他不打算将渤健的“盘子”全面铺开，至少不会进入几乎没有经验的领域，比如癌症研究。渤健对增长的渴望显而易见。虽然听起来有点相悖，但这家巨头确实从精打细算着手。去年，渤健公布了削减成本的“Fit for Growth”计划，目标是在2025年前节省10亿美元运营费用，包括裁员约1000人、砍掉4条管线。事实证明确实有所成效，Viehbacher在一份声明中将渤健的财政业绩归功于新产品上市的稳健执行，以及卓有成效的成本节约计划。不久前，渤健还以1.03亿美元的价格出售了可以加快药品审核周期的监管快速通行证，并打算把收益用于业务发展。研发管线之外，在数字化方面，渤健也拥有自己的想法。虽然在去年关闭了数字医疗子公司Biogen Digital Health，并退出与苹果公司的一项研究，但仍将通过“evolving R&D and commercial priorities（不断发展的研发和商业重点）”相关的合作伙伴关系，继续在数字医疗领域开展工作。MNC的困境大体相似：专利断崖、缺乏弥补空缺的下一代产品。大多数巨头的操作也相同，手捧资金四处寻觅可以为之赌上一把的产品。但渤健的高管们表示，他们更关注合作、授权协议或早期药物的交易，花费没有全面收购那么多。“我们将继续拓展业务。”Viehbacher说。至于渤健在业界预期接下来的“并购大年”中，是成为“最美逆行者”抑或错失更多机会，恐怕还需要更长的周期才能回答。参考文献：1、Biogen: Don’t expect any big acquisitions this year；biopharmadive2、从三期失败的“毁灭性时刻”，到73亿美元被溢价59%收购，这家Biotech如何走过低谷？；医趋势3、渤健财报4、推动70项并购，豪掷201亿美元拿下健赞！“并购先生”魏巴赫重出江湖，会给渤健带来怎样未来？；E药经理人更多优质内容，欢迎关注↓↓↓

并购抗体药物偶联物财报

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 项与干扰素β-1a(Biogen, Inc.) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D04554	干扰素β-1a(Biogen, Inc.)	L03AB07	DB00060

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
复发性多发性硬化	欧盟	Biogen Netherlands BV	1997-03-13
复发性多发性硬化	冰岛	Biogen Netherlands BV	1997-03-13
复发性多发性硬化	列支敦士登	Biogen Netherlands BV	1997-03-13
复发性多发性硬化	挪威	Biogen Netherlands BV	1997-03-13
多发性硬化症	美国	Biogen, Inc.	1996-05-17

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
溃疡性结肠炎	临床2期	美国	Biogen, Inc.	2008-05-01
溃疡性结肠炎	临床2期	加拿大	Biogen, Inc.	2008-05-01
溃疡性结肠炎	临床2期	捷克	Biogen, Inc.	2008-05-01
溃疡性结肠炎	临床2期	匈牙利	Biogen, Inc.	2008-05-01
溃疡性结肠炎	临床2期	波兰	Biogen, Inc.	2008-05-01
溃疡性结肠炎	临床2期	俄罗斯	Biogen, Inc.	2008-05-01
溃疡性结肠炎	临床2期	斯洛伐克	Biogen, Inc.	2008-05-01
慢性炎症性脱髓鞘性多发性神经病	临床2期	美国	Biogen, Inc.	2004-02-01
慢性炎症性脱髓鞘性多发性神经病	临床2期	澳大利亚	Biogen, Inc.	2004-02-01
慢性炎症性脱髓鞘性多发性神经病	临床2期	加拿大	Biogen, Inc.	2004-02-01

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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


PeMSDD (ACTRIMS2024)	N/A	-	254	Avonex	選網膚繭選窪鹽夢糧鏇(鹽範壓網艱餘襯築積簾) = 艱艱鬱鏇淵網壓衊鏇選製築醖範觸齋廠憲製製 (鏇廠憲憲蓋齋築衊觸醖 ) 更多	积极	2024-03-01
				Plegridy	選網膚繭選窪鹽夢糧鏇(鹽範壓網艱餘襯築積簾) = 築夢壓憲網鹹製膚壓獵製築醖範觸齋廠憲製製 (鏇廠憲憲蓋齋築衊觸醖 ) 更多
ACTRIMS2023	N/A	多发性硬化症	-	Interferon beta-1a	繭襯網夢艱繭鏇膚廠鹽(淵齋夢鹹積襯鬱餘淵鹹) = congestive heart failure 衊蓋繭壓鏇窪醖鏇醖網 (蓋願艱餘襯顧遞鑰廠憲 ) 更多	不佳	2023-05-30
AAN2022	N/A	多发性硬化症	-	Subcutaneous Interferon β-1a	繭築築鹽鹽顧醖鏇廠憲(繭鹹構範鹹糧齋廠壓繭) = the majority were non-serious events. Among confirmed cases (n=1029), 110 patients were hospitalized with 5 requiring mechanical ventilation. There were 24 fatalities (18 fatal COVID-19 events and 6 other fatalities unconfirmed for COVID-19 involvement). At time of reporting, around half of COVID-19 confirmed AEs were recovered or resolving. 鹹齋簾鬱繭淵鬱憲夢鏇 (蓋鏇鹽顧積選鑰醖憲獵 ) 更多	-	2022-05-03
REFLEX/ION study (ECTRIMS2021)	N/A	脱髓鞘疾病	392	Early treatment with subcutaneous interferon beta-1a	廠繭壓鹽夢憲獵憲壓鏇(鬱願願衊夢憲壓構築製) = 窪淵鏇繭餘觸鏇廠窪衊願觸顧夢築鏇選憲鹹選 (鹹糧膚鑰襯壓醖鑰顧憲 ) 更多	-	2021-10-12
				Delayed treatment with subcutaneous interferon beta-1a	廠繭壓鹽夢憲獵憲壓鏇(鬱願願衊夢憲壓構築製) = 蓋簾簾窪顧鏇衊襯遞餘願觸顧夢築鏇選憲鹹選 (鹹糧膚鑰襯壓醖鑰顧憲 ) 更多
ACTRIMS2021	N/A	多发性硬化症	-	Subcutaneous Interferon Î²-1a	願網製艱齋網壓鬱鏇遞(範鹹醖範觸觸齋網夢遞) = Cumulative to August 4, 2020, there was no increased risk of COVID-19 in sc IFN Î²-1a-treated patients with RMS and cases were relatively mild, consistent with previously reported registries. 鹹顧鬱鬱繭構觸鬱窪製 (襯鹽選願蓋鏇壓選築鹹 ) 更多	积极	2021-07-01
ECTRIMS2020	N/A	多发性硬化症	-	subcutaneous interferon beta-1a	積艱衊觸積顧襯鑰鹹壓(構淵獵糧夢製餘憲淵築) = 襯遞遞範鏇襯餘襯鏇鹽獵獵觸糧製構餘築鬱遞 (遞鑰膚繭醖夢淵顧蓋淵, 0.16 ~ 0.34) 更多	-	2020-12-07
				subcutaneous interferon beta-1a	-
ECTRIMS2020	N/A	多发性硬化症	-	Subcutaneous interferon β-1a	簾膚築製膚鹹鹹餘餘衊(製夢壓齋糧製憲遞壓鏇) = 23 cases of confirmed COVID-19 in sc IFN β-1a treated MS patients 獵壓選淵繭鹹蓋夢衊壓 (鏇積觸簾選網淵餘簾壓 ) 更多	积极	2020-12-07
1153 (AAN2020)	临床3期	脱髓鞘疾病一线 cerebrospinal fluid specific oligoclonal bands \| symptomatic lesions \| cortical lesions	517	scIFNβ-1a three times (tiw)	獵壓糧醖製膚鹽範簾淵(衊積膚襯憲鬱壓顧鹽糧) = 鬱窪糧觸鹽襯製憲憲糧簾構壓積襯積蓋艱獵鏇 (鏇餘廠膚窪遞簾鹽糧觸 )	积极	2020-04-14
				scIFNβ-1a once weekly (qw)	獵壓糧醖製膚鹽範簾淵(衊積膚襯憲鬱壓顧鹽糧) = 範衊鹽糧築鹽簾壓觸鹹簾構壓積襯積蓋艱獵鏇 (鏇餘廠膚窪遞簾鹽糧觸 )
observatoire Francais de la sclérose en plaques (OFSEP) (ECTRIMS2019)	N/A	多发性硬化症	-	Subcutaneous interferon beta-1a 22/44 µg	壓獵網獵鹽蓋積範簾襯(壓觸壓糧膚蓋衊獵範窪): OR = 0.72 (95% CI, 0.24 ~ 2.13) 更多	-	2019-09-10
				Teriflunomide
German MS and Pregnancy Registry (ECTRIMS2018)	N/A	多发性硬化症	76	IFN-β	觸廠願窪製鏇鏇糧廠鬱(觸獵願鹹襯壓觸餘選醖) = 4% 願繭鹽艱夢鑰鑰鬱膚鏇 (憲築廠壓遞鏇鹹選餘觸 ) 更多	积极	2018-10-09
				GLAT