The primary objective of the study is to estimate the incidence rate of serious adverse events (SAEs), including but not limited to malignancies and serious and opportunistic infections, among participants with MS treated with Vumerity, Tecfidera, other selected disease modifying therapies (DMTs [teriflunomide, beta interferons, or glatiramer acetate]), or Vumerity after switching from Tecfidera. The secondary objective of the study is to compare the incidence rate of SAEs, including but not limited to malignancies and serious and opportunistic infections, among MS participants treated with Vumerity, Tecfidera, and Vumerity after switching from Tecfidera with the incidence rate of MS participants treated with other selected DMTs (teriflunomide, beta-interferons, or glatiramer acetate), if the sample size allows.

开始日期2024-09-01

申办/合作机构

Biogen, Inc.

NCT06432764 / Not yet recruiting临床1期

A Phase Ib Open Label Positron Emission Tomography Study to Assess Changes in Intestinal [11C]AZ14132516 Uptake Following Administration of Multiple Doses of AZD7798 to Patients With Crohn's Disease.

The purpose of this study is to measure the changes in intestinal uptake of radioligand [11C]AZ14132516 following multiple doses of AZD7798 in participants with Crohn's disease.

开始日期2024-08-30

申办/合作机构

AstraZeneca PLC

NCT06319339 / Not yet recruiting早期临床1期IIT

Impact of Nrf2 Activation on Macrovascular Function, Microvascular Function, Leg Function, and Walking Capacity in Patients With Peripheral Artery Disease

Purpose: Peripheral artery disease (PAD) is associated with elevated oxidative stress, and oxidative stress has been implicated as the cause of reduced endothelial reactivity in individuals with PAD. Endothelial function is important because the endothelium contributes to the dilation of arteries during exercise, thereby implicating impaired endothelial function as a mechanism contributing to exacerbated exercise-induced ischemia. Therefore, the purpose of this study is to test the hypothesis that acute exogenous diroximel fumarate (Vumerity) intake will improve antioxidant capacity, thereby reducing oxidative stress and improving vascular function and walking capacity in those with PAD. Eligibility: Individuals with PAD will be deemed eligible for this study if they 1) are 50-75 years old and postmenopausal, 2) have a positive history of exercise-limiting claudication (Fontaine II or III), 3) do not have renal impairments, 4) do not have Fontaine stage IV PAD, and 5) are not currently pregnant or nursing. Age-matched controls will be deemed eligible for this study if they 1) are 50-75 years old and postmenopausal, 2) have an ABI greater than 0.9 (no PAD), 3) do not have exercise-limiting diseases or injuries, 4) do not have renal impairments, and 5) are not currently pregnant or nursing. Intervention and Evaluation: During this study, participants will be administered diroximel fumarate or a placebo, and the acute effects of diroximel fumarate on vascular function and walking capacity will be assessed. Vascular function and walking capacity will be assessed with flow-mediated dilation, arterial stiffness, head-up tilt test, blood biomarkers, near-infrared spectroscopy, and a treadmill test. Follow-up: There will be a follow-up visit to assess blood work after diroximel fumarate.

开始日期2024-08-01

申办/合作机构

University of Nebraska

100 项与富马酸地罗西美相关的临床结果

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100 项与富马酸地罗西美相关的转化医学

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100 项与富马酸地罗西美相关的专利（医药）

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项与富马酸地罗西美相关的文献（医药）

2024-02-01·Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA

Epidemiology of distal radius fractures in Germany - incidence rates and trends based on inpatient and outpatient data

Article

作者: Haastert, Burkhard ; Arend, Werner ; Reiland, Kevin ; Icks, Andrea ; Thelen, Simon ; Andrich, Silke ; Klüppelholz, Birgit ; Windolf, Joachim

PURPOSE:

Although a distal radius fracture (DRF) is one of the most common fractures in the elderly population, epidemiological data are limited. Many studies examine only hospitalized patients, do not analyze time trends, or include only small populations. In this retrospective population-based observational study, routine data on inpatient and outpatient care of persons aged ≥ 60 years insured by a large statutory health insurance in Germany were analyzed from 2014 to 2018.

METHODS:

DRF were identified by ICD-10 codes. All DRF events of an individual were considered with a corresponding individual washout period. Incidence rates (IR) and time trends were estimated assuming a Poisson distribution per 100,000 person-years, with 95% confidence intervals [95% CI] and age-sex standardization to the German population in 2018. Associations of calendar year, age, sex, and comorbidity with IR were examined using Poisson regression estimating incidence rate ratios (IRR) with CI.

RESULTS:

The study population consists of 974,332 insured individuals, with 16,557 experiencing one or more DRF events during the observation period. A total of 17,705 DRF events occurred, of which 9961 (56.3%) were hospitalized. Standardized IR were 439 [424-453] (inpatient: 240 [230-251], outpatient: 199 [189-209]) in 2014 and 438 [423-452] (inpatient: 238 [227-249], outpatient: 200 [190-210]) in 2018. Female sex, older age, and comorbidity were associated with higher IR and adjusted Poisson regression showed no significant time trend (IRR overall 0.994 [0.983-1.006]).

CONCLUSION:

A relevant proportion of DRF were treated in outpatient settings, so both inpatient and outpatient data are necessary for a valid estimate.

2024-01-01·Experimental neurology

Assessing neuroprotective effects of diroximel fumarate and siponimod via modulation of pacemaker channels in an experimental model of remyelination

Article

作者: Budde, Thomas ; White, John A ; Oniani, Tengiz ; Kovac, Stjepana ; Meuth, Sven G ; Vinnenberg, Laura ; Williams, Brandon ; Rychlik, Nicole ; Hundehege, Petra

Cuprizone (CPZ)-induced alterations in axonal myelination are associated with a period of neuronal hyperexcitability and increased activity of hyperpolarization-activated and cyclic nucleotide-gated (HCN) channels in the thalamocortical (TC) system. Substances used for the treatment of multiple sclerosis (MS) have been shown to normalize neuronal excitability in CPZ-treated mice. Therefore, we aimed to examine the effects of diroximel fumarate (DRF) and the sphingosine 1-phospate receptor (S1PR) modulator siponimod on action potential firing and the inward current (I_h) carried by HCN ion channels in naive conditions and during different stages of de- and remyelination. Here, DRF application reduced I_h current density in ex vivo patch clamp recordings from TC neurons of the ventrobasal thalamic complex (VB), thereby counteracting the increase of I_h during early remyelination. Siponimod reduced I_h in VB neurons under control conditions but had no effect in neurons of the auditory cortex (AU). Furthermore, siponimod increased and decreased AP firing properties of neurons in VB and AU, respectively. Computational modeling revealed that both DRF and siponimod influenced thalamic bursting during early remyelination by delaying the onset and decreasing the interburst frequency. Thus, substances used in MS treatment normalize excitability in the TC system by influencing AP firing and I_h.

2023-12-01·Neurology and therapy

Letter to the Editor Regarding: “Real-World Analysis Affirms the High Persistence and Adherence Observed with Diroximel Fumarate in Patients with Multiple Sclerosis”

Letter

作者: Castaño-Amores, Celia ; Nieto-Gómez, Pelayo

项与富马酸地罗西美相关的新闻（医药）

2024-05-01

·PRNewswire

Alkermes plc Reports First Quarter 2024 Financial Results

— First Quarter Revenues of $350.4 Million — — GAAP Net Income from Continuing Operations of $38.9 Million and Diluted GAAP Earnings per Share from Continuing Operations of $0.23 — — Company Reiterates 2024 Financial Expectations — DUBLIN, May 1, 2024 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today reported financial results for the first quarter of 2024. "The first quarter of 2024 marks our first full quarter as a profitable, pure-play neuroscience company. During the quarter, we continued to advance our strategic priorities across the business, highlighted by solid underlying prescription growth for LYBALVI® and advancement of ALKS 2680, our novel, investigational, oral orexin 2 receptor (OX2R) agonist in development as a once-daily treatment for narcolepsy," said Richard Pops, Chief Executive Officer of Alkermes. "For ALKS 2680, we recently initiated our Vibrance-1 phase 2 study in narcolepsy type 1 and announced positive topline phase 1b results in narcolepsy type 2. With these new data now in hand, we plan to initiate a phase 2 study in narcolepsy type 2 in the second half of 2024. In an area where there remains significant unmet patient need, orexin 2 biology represents an important new potential approach to treating disorders characterized by excessive daytime sleepiness. ALKS 2680 is the first candidate from our orexin portfolio to advance in the clinic and we plan to share details regarding our other orexin development programs later this year." Key Financial Highlights Revenue Highlights LYBALVI Revenues for the quarter were $57.0 million. Revenues and total prescriptions for the quarter grew 50% and 56%, respectively, compared to the first quarter of 2023. Inventory in the channel decreased by approximately $2.3 million during the quarter. ARISTADAi Revenues for the quarter were $78.9 million. Inventory in the channel decreased by approximately $3.6 million during the quarter. VIVITROL Revenues for the quarter were $97.7 million. Inventory in the channel decreased by approximately $4.3 million during the quarter. Manufacturing & Royalty Revenues Royalty revenues from INVEGA SUSTENNA®/XEPLION®, INVEGA TRINZA®/TREVICTA® and INVEGA HAFYERA®/BYANNLI® for the quarter were $62.7 million. VUMERITY® manufacturing and royalty revenues for the quarter were $31.3 million. Key Operating Expenses Please see Note 1 below for details regarding discontinued operations. Year-over-year increase in R&D expense related to continuing operations was driven primarily by investment in the ALKS 2680 development program and approximately $3.2 million of non-recurring share-based compensation expenses. Year-over-year increase in SG&A expense related to continuing operations was driven primarily by investment in the LYBALVI direct-to-consumer advertising campaign and approximately $6.2 million of non-recurring share-based compensation expenses. Balance Sheet At March 31, 2024, the company recorded cash, cash equivalents and total investments of $807.8 million, compared to $813.4 million at Dec. 31, 2023. The company's total debt outstanding as of March 31, 2024 was $290.1 million. Financial Expectations for 2024 Alkermes reiterates its financial expectations for 2024, as set forth in its press release dated Feb. 15, 2024. Recent Events In March 2024, the company announced the appointment of new independent director Nancy S. Lurker to the company's board of directors. In April 2024, the company presented data from its long-term safety study of LYBALVI (olanzapine and samidorphan) at the 2024 Congress of the Schizophrenia International Research Society (SIRS). In April 2024, the company announced positive topline results from the narcolepsy type 2 and idiopathic hypersomnia cohorts in its phase 1b study of ALKS 2680, the company's novel, investigational orexin 2 receptor (OX2R) agonist in development as a once-daily treatment for narcolepsy. In April 2024, the company announced initiation of the Vibrance-1 phase 2 study of ALKS 2680 in patients with narcolepsy type 1. Notes and Explanations 1. The company determined that upon the separation of its oncology business, completed on Nov. 15, 2023, the oncology business met the criteria for discontinued operations in accordance with Financial Accounting Standards Board Accounting Standards Codification 205, Discontinued Operations. Accordingly, the accompanying selected financial information has been updated to present the results of the oncology business as discontinued operations for the three months ended March 31, 2023. Conference Call Alkermes will host a conference call and webcast presentation with accompanying slides at 8:00 a.m. ET (1:00 p.m. BST) on Wednesday, May 1, 2024, to discuss these financial results and provide an update on the company. The webcast may be accessed on the Investors section of Alkermes' website at . The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers. In addition, a replay of the conference call may be accessed by visiting Alkermes' website. About Alkermes plc Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders, including narcolepsy. Headquartered in Ireland, Alkermes also has a corporate office and research and development center in Massachusetts and a manufacturing facility in Ohio. For more information, please visit Alkermes' website at . Non-GAAP Financial Measures This press release includes information about certain financial measures that are not prepared in accordance with generally accepted accounting principles in the U.S. (GAAP), including non-GAAP net income and EBITDA. These non-GAAP measures are not based on any standardized methodology prescribed by GAAP and are not necessarily comparable to similar measures presented by other companies. Non-GAAP net income adjusts for certain one-time and non-cash charges by excluding from GAAP results: share-based compensation expense; amortization; depreciation; non-cash net interest expense; change in the fair value of contingent consideration; certain other one-time or non-cash items; and the income tax effect of these reconciling items. EBITDA represents earnings before interest, tax, depreciation and amortization; earnings include share-based compensation expense. The company's management and board of directors utilize these non-GAAP financial measures to evaluate the company's performance. The company provides these non-GAAP financial measures of the company's performance to investors because management believes that these non-GAAP financial measures, when viewed with the company's results under GAAP and the accompanying reconciliations, are useful in identifying underlying trends in ongoing operations. However, non-GAAP net income and EBITDA are not measures of financial performance under GAAP and, accordingly, should not be considered as alternatives to GAAP measures as indicators of operating performance. Further, non-GAAP net income and EBITDA should not be considered measures of the company's liquidity. A reconciliation of GAAP to non-GAAP financial measures has been provided in the tables included in this press release. Note Regarding Forward-Looking Statements Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning: the company's expectations concerning its future financial and operating performance, business plans or prospects; the company's expectations regarding advancement of its development pipeline, including plans and expected timelines for the ALKS 2680 clinical development program; and the therapeutic and commercial potential of ALKS 2680 and the company's other development programs. The company cautions that forward-looking statements are inherently uncertain. The forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: whether the company is able to sustain profitability; the unfavorable outcome of arbitration or litigation, including so-called "Paragraph IV" litigation and other patent litigation which may lead to competition from generic drug manufacturers, or other disputes related to the company's products or products using the company's proprietary technologies; clinical development activities may not be completed on time or at all; the results of the company's development activities may not be positive, or predictive of final results from such activities, results of future development activities or real-world results; the U.S. Food and Drug Administration (FDA) or regulatory authorities outside the U.S. may not agree with the company's regulatory approval strategies; the FDA or regulatory authorities outside the U.S. may make adverse decisions regarding the company's products; the company and its licensees may not be able to continue to successfully commercialize their products or support revenue growth from such products; there may be a reduction in payment rate or reimbursement for the company's products or an increase in the company's financial obligations to government payers; the company's products may prove difficult to manufacture, be precluded from commercialization by the proprietary rights of third parties, or have unintended side effects, adverse reactions or incidents of misuse; and those risks and uncertainties described under the heading "Risk Factors" in the company's Annual Report on Form 10-K for the year ended Dec. 31, 2023 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC's website at . Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release. VIVITROL® is a registered trademark of Alkermes, Inc.; ARISTADA®, ARISTADA INITIO® and LYBALVI® are registered trademarks of Alkermes Pharma Ireland Limited, used by Alkermes, Inc. under license; BYANNLI®, INVEGA HAFYERA®, INVEGA SUSTENNA®, INVEGA TRINZA®, TREVICTA® and XEPLION® are registered trademarks of Johnson & Johnson or its affiliated companies; and VUMERITY® is a registered trademark of Biogen MA Inc., used by Alkermes under license. Alkermes Contacts: For Investors: Sandy Coombs +1 781 609 6377 For Media: Katie Joyce +1 781 249 8927 SOURCE Alkermes plc

临床2期财报临床1期临床结果高管变更

2024-04-26

·BiG生物创新社

渤健Q1财报公布，阿尔茨海默病资产Leqembi远超预期！

作者｜YY 渤健（Biogen Inc）刚刚公布的第一季度财报显示其利润超过预期，尤其是备受关注的阿尔茨海默病Leqembi的销售业绩也高于预期。 01 渤健Q1财报，Leqembi开始上位图片来源：卫材Leqembi去年1月获得FDA加速批准，并于当年7月迅速升级为全面批准。虽然开发商渤健和卫材并没有急于将Leqembi推向市场，但上市后市场吸收率在今年第一季度突然提速，获得了1900万美元的销售额，几乎是去年第四季度销售额的三倍，高于分析师预测的1100万美元，也超过了去年1000万美元业绩。公布财报后，渤健的股价立即上涨了6%。据渤健称，自 2023 年底以来，接受Leqembi的患者数量增加了近 2.5 倍，3 月份开始新患者数量激增，占总患者人数的20% 以上。对于Leqembi患者人数增加的背后原因，渤健认为随着医生团体和医疗中心诊断、监测所需的所有后勤设置的到位，Leqembi 的迅速上位自然就是水到渠成的事情。但Leqembi的壮大道路也并非一番坦途。卫材设定了3月底吸引1万名美国患者的“小目标”，但CMS (医疗保险和医疗补助服务中心) 提供的信息显示，截至4月初，只有5600 名患者获准接受治疗。繁缛的治疗过程、高昂的费用和对副作用的担心限制了Leqemi大展宏图。患者在18个月的疗程中需要接受38次输注，但首先需要进行 PET 脑部扫描和定期 MRI 扫描，五分之一的患者会受到破坏性副作用的影响。除此之外，Medicare不愿意为65 岁以上的人支付昂贵的扫描费用，而一些神经科医生掣肘于Leqembi背后的风险和有限的疗效而选择不开具Leqembi处方。渤健和卫材2021 年推出的阿尔茨海默病药物Aduhelm 的黯然收场令很多医生和患者对此类药物可能的副作用非常忌惮。除此之外，Leqembi 的售价为每年 26500 美元，并且带有脑水肿和脑出血ARIA（Amyloid related imaging abnormalities）黑框警告。FDA 3月份推迟了礼来的阿尔茨海默病药物Donanemab的批准决定，这突显了他们在批准此类药物时的谨慎态度。临床试验发现，donanemab需要每月输注以清除患者大脑中的淀粉样蛋白，因此脑水肿的发生率更高。尽管面临着高成本、高风险和有限疗效的限制，但考虑到700万美国患者和5000万全球患者，分析师预计leqembi和donanemab未来的销售量将保持高水准。据彭博社数据，到 2030 年，Leqembi 和 donanemab 预计每年将分别产生 22 亿美元和 55 亿美元的收入（图1）。图1. 阿尔茨海默病药物Leqembi和donanemab预计销售量走势图。（图片来源：Financial Times）尽管新一代阿尔茨海默病疗法在研究和治疗领域取得了一些进展，但简化给药过程中所需的管理任务仍然有待解决。渤健和卫材四月初决定推迟每周皮下注射版 Leqembi 的监管申请，这主要是因为 FDA 要求提供三个月的额外免疫反应数据。从监测方面来看，分析β淀粉样蛋白片段的血液检测无需花费 5000 美元的 PET 扫描，商业化后并未广泛使用，然而大约一半患者最初会被 Medicare Advantage 计划拒绝接受 PET 扫描承保。对于Leqembi的未来地位，CMS发言人最近发表了一番预测，预计Leqembi 2024年的Medicare成本将为5.5亿美元，到2025年将猛增至35亿美元。考虑到Medicare精算师在预测方面众所周知的保守性，35亿美元的预测尤其令人意外。这甚至超过了卫材自己的预测，他们3月刚刚宣称，Leqembi到2026财年（2026年4月到2027年3月）在北美洲和南美洲的销售额合计将达到13亿美元，这只是CMS 2025年预测值的三分之一多。 02 渤健Q1表现如何？虽然Leqembi传来捷报，但渤健本季度22.9亿美元的销售额同比下降 7%。第一季度净利润为 3.934 亿美元，略高于去年同期的净利润 3.879 亿美元。Skyclarys渤健7 月份收购 Reata Pharmaceuticals 带来的资产Skyclarys在今年第一季度收入了7800 万美元，高于FactSet分析师预计的6880万美元。FDA去年批准的Skyclarys是史上首款获批的弗里德赖希共济失调症疗法。这是一种罕见的遗传性退行性疾病，可损害年仅 5 岁儿童的行走和协调能力。今年2 月获得了欧盟委员会批准。渤健表示，美国和欧盟目前分别有1100名和300名患者正在使用Skyclarys。首款产后抑郁症药物Zurzuvae去年8月，Biogen 与 Sage Therapeutics 合作开发的首款产后抑郁症药物Zurzuvae获得FDA批准，但针对更大适应症重度抑郁症的申请遭到了拒绝。Zurzuvae第一季度销售额达 1200 万美元，远高于FactSet分析师此前500万美元的预估。受到仿制药竞争带来的影响，渤健第一季度多发性硬化症产品收入下降 4% ，跌至10.8 亿美元。渤健曾经的重磅炸弹Tecfidera第一季度的销售额为 2.543 亿美元，低于去年第一季度的2.745 亿美元。复发型多发性硬化症的口服药物Vumerity第一季度的销售额达 1.275 亿美元。罕见病药物类渤健的罕见病药物销售额为 4.239 亿美元，低于去年同期的 4.433 亿美元。罕见神经肌肉疾病脊髓性肌萎缩症疗法Spinraza第一季度销售额为 3.413 亿美元，低于分析师预计的 4.151 亿美元。生物类似药生物类似药方面，渤健第一季度的销售额为1.969亿美元，高于去年同期的1.924亿美元。Ref.Constantino, A. K. Biogen tops profit estimates as cost cuts take hold, Alzheimer’s drug Leqembi launch picks up. CNBC. 24. 04. 2024.Feuerstein, A. Biogen’s Alzheimer’s drug launch on ‘steady pace’ as logistical hurdles recede. STAT. 24. 04. 2024.Barnes, O. Alzheimer’s drug Leqembi falls short of blockbuster status in faltering US rollout. Fanancial Times. 22. 04. 2024.Herman, B. et al. Medicare expects to spend $3.5 billion on new Alzheimer’s drug in 2025. STAT. 11. 04. 2024. BiG 十周年预告本次BiG十周年庆典，将首次分为国内和国际篇章，以原创科学和临床需求为出发点，讨论创新技术平台和创新疗法（PROTACT/分子胶、双抗/ADC、siRNA/ASO、CGT、AI制药）的重大进展和发展前景，十年一药曙光现，大浪淘沙始见金！▼报名参会会议门票：审核制(免费)；含主论坛+分论坛，不含餐；优先biotech/Pharma、临床、院校科学家共建Biomedical创新生态圈！如何加入BiG会员？

财报加速审批信使RNA

2024-02-14

·BioSpace

DOJ, SEC Subpoenas Add to Biogen’s Compounding Problems

Pictured: Biogen's office and lab buildings in Cambridge, Massachusetts/iStock, hapabapa Biogen has disclosed in a Wednesday Securities and Exchange Commission filing that it has been served a subpoena by the U.S. Department of Justice, which is seeking more information regarding the company’s overseas operations. The Securities and Exchange Commission (SEC) has also issued subpoenas to Biogen, asking for additional information regarding the launch of its abandoned Alzheimer’s disease therapy Aduhelm (aducanumab), the company reported. In connection with the Department of Justice subpoena, Biogen is “providing information relating to our business operations in several foreign countries to the SEC,” it noted in Wednesday’ filing. Outside the U.S., Biogen has established a presence in more than 40 territories, according to its website. These include Australia, Canada, China, Japan and several European countries. Biogen’s international headquarters is in Switzerland. BioSpace reached out to Biogen for comment on the U.S. government investigations but the company was not immediately available. The news of the subpoenas come one day after Biogen reported its fourth-quarter and full-year financial results, posting disappointing sales figures and plotting a bleak forecast for 2024. In the fourth quarter of 2023, the pharma made over $2.3 billion in revenue, a 5% decline from the same period the prior year. Its multiple sclerosis business, anchored by Fampyra (fampridine), Tecfidera (dimethyl fumarate) and Vumerity (diroximel fumarate), suffered an 8% sales hit, bringing in only $1.1 billion in the most recent quarter. Tecfidera contributed heavily to Biogen’s poor financial performance, with its revenues tanking 17.8% in the fourth quarter. Though relatively small, Biogen also absorbed $60 million in close-out costs associated with Aduhelm. Late last month, the pharma announced that it would discontinue the development and commercialization of the controversial Alzheimer’s therapy and instead channel its resources and energy into Leqembi (lecanemab). CEO Chris Viehbacher called this decision “difficult” on Tuesday, but one that represents the most efficient use of the company’s capital. “By the time Aduhelm would get its confirmatory data we just felt that Leqembi would be so far ahead and there are going to be other agents.” Leqembi’s launch, however, has been slow. Eisai—Biogen’s development and commercialization partner for the Alzheimer’s therapy—reported last week that it will likely miss its March 2024 goal of treating 10,000 patients. Since winning the FDA’s full approval in July 2023, Leqembi has only reached around 2,000 patients so far, with about 8,000 more on waitlists. In the face of these compounding problems, Biogen CFO Mike McDonald said during the investor call on Tuesday that the company is expecting a low-to-mid-single-digit percentage drop in revenue in 2024, while its core revenue from products would be relatively flat. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

上市批准财报加速审批

100 项与富马酸地罗西美相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11154	-	L03	DB14783

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-缓解型多发性硬化	欧盟	Biogen Netherlands BV	2021-11-15
复发-缓解型多发性硬化	冰岛	Biogen Netherlands BV	2021-11-15
复发-缓解型多发性硬化	列支敦士登	Biogen Netherlands BV	2021-11-15
复发-缓解型多发性硬化	挪威	Biogen Netherlands BV	2021-11-15
多发性硬化症	瑞士	Biogen, Inc.	2021-09-20
复发性多发性硬化	美国	Biogen, Inc.	2019-10-29

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
GM1神经节苷脂贮积病	临床3期	美国	Biogen, Inc.	2015-12-10
GM1神经节苷脂贮积病	临床3期	比利时	Biogen, Inc.	2015-12-10
GM1神经节苷脂贮积病	临床3期	保加利亚	Biogen, Inc.	2015-12-10
GM1神经节苷脂贮积病	临床3期	加拿大	Biogen, Inc.	2015-12-10
GM1神经节苷脂贮积病	临床3期	德国	Biogen, Inc.	2015-12-10
GM1神经节苷脂贮积病	临床3期	波兰	Biogen, Inc.	2015-12-10
GM1神经节苷脂贮积病	临床3期	俄罗斯	Biogen, Inc.	2015-12-10
GM1神经节苷脂贮积病	临床3期	塞尔维亚	Biogen, Inc.	2015-12-10
GM1神经节苷脂贮积病	临床3期	西班牙	Biogen, Inc.	2015-12-10
GM1神经节苷脂贮积病	临床3期	乌克兰	Biogen, Inc.	2015-12-10

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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


ECTRIMS2023	N/A	多发性硬化症	29	Dimethyl Fumarate (DMF)	顧艱壓壓醖積鹹糧繭遞(範糧鹽網構獵衊願鏇齋) = The incidence of lymphopenia (ALC <910) in this cohort of PwMS who transitioned from DMF to DRF increased from 24% at baseline to 52% 12 months after treatment change. 顧夢鬱選鬱積遞憲築獵 (糧蓋鹹襯蓋鬱遞顧選蓋 ) 更多	积极	2023-10-01
ECTRIMS2023	N/A	淋巴细胞减少	72	Dimethyl Fumarate (DMF)	選鏇淵憲築網鏇網積遞(選網築齋築衊獵網壓廠) = 選築簾願願鑰願壓鏇鏇鏇憲壓憲顧醖網製夢繭 (顧築獵鑰願淵膚齋淵廠 )	-	2023-09-30
				Diroximel Fumarate (DRF)	選鏇淵憲築網鏇網積遞(選網築齋築衊獵網壓廠) = 築糧鬱範鹽選範齋觸窪鏇憲壓憲顧醖網製夢繭 (顧築獵鑰願淵膚齋淵廠 )
ECTRIMS2023	N/A	神经炎症	-	Diroximel fumarate (DRF)	窪網鏇餘艱廠艱簾淵壓(網積鑰糧築夢鏇獵夢獵) = significantly reduced IFNγ secretion in splenocytes isolated from DRF treated mice 壓夢糧憲醖艱壓願遞鏇 (築築糧顧襯繭簾淵顧繭 ) 更多	积极	2023-09-30
				Vehicle (methocel)
SUNBEAM (RPC01-301), RADIANCE phase 3 (RPC01-201B), EVOLVE-MS-1 (ACTRIMS2023)	临床3期	复发-缓解型多发性硬化	-	Ozanimod 1.0 mg	糧鏇選餘選憲壓顧簾餘(襯蓋憲鏇齋獵製鏇遞醖): risk ratio = 0.924 (95% CI, 0.646 ~ 1.324) 更多	积极	2023-05-30
				Diroximel fumarate 462 mg
ACTRIMS2023	N/A	多发性硬化症	11	Diroximel Fumarate	願遞築淵積鹽醖夢膚鹽(鬱窪衊醖衊鹽糧夢遞製) = 糧鏇壓襯襯鹹齋願築鹹鹽鑰鏇壓鏇衊齋廠壓蓋 (遞鬱繭製壓製窪淵鏇廠 ) 更多	积极	2023-05-30
				Dimethyl Fumarate	願遞築淵積鹽醖夢膚鹽(鬱窪衊醖衊鹽糧夢遞製) = 願廠艱膚製願選選獵衊鹽鑰鏇壓鏇衊齋廠壓蓋 (遞鬱繭製壓製窪淵鏇廠 ) 更多
EVOLVE-MS-1, OPTIMUM (Pubmed)	临床3期	复发性多发性硬化	-	Diroximel fumarate	憲鑰網構鹽夢艱壓顧簾(餘鏇製顧廠憲憲鹹網構) = 鏇繭遞繭繭廠構廠醖襯鏇構製鑰鏇範憲遞繭鹹 (鹹積夢構選網夢餘夢鹽 )	-	2023-05-08
NCT02634307 (EVOLVE-MS-1, AAN2023)	临床3期	复发-缓解型多发性硬化	239	Diroximel Fumarate	夢築繭顧繭範顧簾齋簾(糧獵淵願蓋獵膚餘觸齋) = 23 (9.6%) patients discontinued DRF due to adverse events 網製鑰襯襯憲築顧襯製 (膚繭構願襯鹹醖範糧艱 ) 更多	积极	2023-04-25
NCT02634307 (EVOLVE-MS-1, AAN2023)	临床3期	多发性硬化症	1,057	Diroximel fumarate	鏇齋淵繭餘壓齋膚築願(憲艱築觸鏇蓋壓選糧襯) = 糧餘鏇簾積繭顧夢製遞衊鹽鬱糧醖獵壓繭繭鑰 (獵鹹夢窪醖衊繭衊鹹簾 ) 更多	积极	2023-04-25
				Placebo	鏇齋淵繭餘壓齋膚築願(憲艱築觸鏇蓋壓選糧襯) = 鹹壓觸憲醖網繭構選繭衊鹽鬱糧醖獵壓繭繭鑰 (獵鹹夢窪醖衊繭衊鹹簾 ) 更多
NCT02634307 (CTgov)	临床3期	复发-缓解型多发性硬化 \| GM1神经节苷脂贮积病	1,057	ALKS 8700+DMF (De Novo)	淵範鏇夢艱餘艱齋鹹積(範觸齋鏇鏇鬱蓋醖築廠) = 繭獵願構選築窪鬱襯鹹廠範衊願夢簾膚鬱壓鏇 (廠膚憲艱製壓憲淵廠遞, 選觸齋觸願壓醖夢憲簾 ~ 壓鑰獵餘獵繭製鹽積範) 更多	-	2022-06-24
				ALKS 8700 (Rollover: ALKS 8700)	淵範鏇夢艱餘艱齋鹹積(範觸齋鏇鏇鬱蓋醖築廠) = 夢鑰網鏇築膚顧顧願艱廠範衊願夢簾膚鬱壓鏇 (廠膚憲艱製壓憲淵廠遞, 鬱鏇鹹鏇鹽築製夢遞齋 ~ 鹹積選繭構鑰構鬱鹽鏇) 更多
P9-4.007 (AAN2022)	N/A	多发性硬化症	-	Diroximel Fumarate	齋醖襯廠膚鑰獵顧構壓(築糧廠艱築遞糧願鹽築) = 繭積淵觸鏇餘簾壓襯遞窪衊遞壓夢鑰選鬱憲蓋 (構願鏇鑰夢廠範蓋淵鹹, 89.2 ~ 92.5) 更多	积极	2022-05-03
				Prior DMF	齋醖襯廠膚鑰獵顧構壓(築糧廠艱築遞糧願鹽築) = 醖顧製鏇遞願選範構膚窪衊遞壓夢鑰選鬱憲蓋 (構願鏇鑰夢廠範蓋淵鹹, 83.3 ~ 87.4)