阿哌沙班(Apixaban) - 药物靶点：factor Xa_在研适应症：复发性深静脉血栓形成，血栓形成，缺血性卒中_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Apixaban (JAN/USAN/INN)、BMS-562247、BMS-562247-01

+ [8]

靶点

factor Xa

作用机制

factor Xa抑制剂(激活型凝血因子X抑制剂)

治疗领域

神经系统疾病心血管疾病呼吸系统疾病+ [1]

在研适应症

复发性深静脉血栓形成血栓形成缺血性卒中+ [8]

非在研适应症

急性冠状动脉综合征急性缺血性卒中急性淋巴细胞白血病+ [20]

原研机构

Bristol Myers Squibb Co.

在研机构

Accord Healthcare SLU

Bristol Myers Squibb Co.Bristol-Myers Squibb/Pfizer EEIG

+ [5]

非在研机构

Pfizer Inc.

Celgene Corp.

江苏万邦生化医药集团有限责任公司

+ [1]

最高研发阶段批准上市

首次获批日期

欧盟 (2011-05-18),

心房颤动栓塞肺栓塞+ [3]

最高研发阶段(中国)批准上市

特殊审评快速通道 (美国)、优先审评 (中国)

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结构

分子式C25H25N5O4

InChIKeyQNZCBYKSOIHPEH-UHFFFAOYSA-N

CAS号503612-47-3

关联

402

项与阿哌沙班相关的临床试验

TCTR20240715013 / Not yet recruiting临床1期IIT

A Bioequivalence study of a randomized, open-label, single dose, two-way crossover design with two-period, two-treatment and two-sequence of Apixaban Tablet 5 mg, relative to EliquisTM, in healthy Thai volunteers under fasting condition

开始日期2025-01-07

申办/合作机构

Bio-innova Co., Ltd

TCTR20240826005 / Not yet recruiting临床1期

A Bioequivalence Study of Two Formulations of Apixaban 5-mg Film-coated Tablets in Healthy Thai Subjects under Fasting Conditions

开始日期2024-11-11

申办/合作机构

Dr. Reddy's Laboratories Ltd.

CTRI/2024/09/074038 / Not yet recruitingN/A

An Open Label Balanced Randomized Single Dose Two Treatment Two Sequence Two Period Two Way Crossover Oral Bioavailability Study Comparing Apixaban 5 Mg Oral Solution 1mg Per Ml Manufactured By Xl Laboratories Pvt Ltd 430 Dlf Towers Shivaji Marg New Delhi 110015 India With Eliquis Apixaban 5 Mg Film Coated Tablets Marketing Authorisation Holder Bristol Myers Squibb Pfizer Eeig Plaza 254 Blanchardstown Corporate Park 2 Dublin 15 D15 T867 Ireland In Healthy Adult Human Subjects Under Fasting Conditions - NIL

开始日期2024-10-02

申办/合作机构-

100 项与阿哌沙班相关的临床结果

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100 项与阿哌沙班相关的转化医学

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100 项与阿哌沙班相关的专利（医药）

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5,255

项与阿哌沙班相关的文献（医药）

2025-01-01·ANNALS OF VASCULAR SURGERY

Postoperative Bleeding Complications are Common among Patients Undergoing Transcarotid Artery Revascularization

Article

作者: Williams, Zachary F ; Southerland, Kevin W ; Southerland, Kevin W. ; Loanzon, Roberto S. ; Williams, Zachary F. ; Loanzon, Roberto S ; Kim, Young ; Cui, Christina L. ; Pride, Laura B ; Pride, Laura B. ; Chun, Tristen T ; Chun, Tristen T. ; Cui, Christina L

BACKGROUND:

Current practice guidelines recommend dual antiplatelet therapy for at least 30 days postoperatively after transcarotid artery revascularization (TCAR) to promote stent patency. However, many patients are already taking other antithrombotic medications. The optimal pharmacologic regimen in this patient population remains unclear, especially as it pertains to postoperative bleeding complications.

METHODS:

All TCAR procedures performed at a large academic medical center from January 1, 2017, to April 30, 2023, were identified via current procedural terminology codes and retrospectively reviewed via electronic medical records. Data were collected on patient demographics, procedural details, postoperative complications, and antithrombotic regimen. Bleeding complications were categorized as surgical and nonsurgical, which included any bleeding diatheses that were not related to the neck incision, such as epistaxis, hematuria, melena, or noncervical hematoma.

RESULTS:

A total of 116 TCAR procedures were performed. The 30-day incidence of bleeding complications was 12.1% (n = 14), which included 8 (6.9%) symptomatic neck hematomas and 6 (5.2%) nonsurgical site bleeding complications. Aside from patient age (median 72 years [66-79] vs. 79 years [70.5-88], P = 0.03), demographics, medical comorbidities, surgical indication, risk-related indication for TCAR, and inpatient/outpatient status were similar between patients who experienced bleeding versus no bleeding complications. Patients who developed bleeding complications experienced higher 30-day hospital readmission (42.9% vs. 9.8%, P < 0.001) and reintervention rates (21.4% vs. 2.0%, P < 0.001) and trended toward longer postoperative length of stay (1.5 days [1-3] vs. 1 [1-2] days, P = 0.07). Reasons for readmission (n = 16) included: epistaxis (1), hematuria (1), headache and melena (1), melena and myocardial infarction (1), fall (1), headache (1), dyspnea (5), delirium (1), diarrhea (1), atrial fibrillation (1), and neck hematoma (1); 1 patient did not have a readmission reason documented. Reinterventions (n = 6) included neck hematoma evacuation (2), epistaxis cauterization (1), emergent cricothyroidotomy (1), and repeat carotid stenting (1). The management of antithrombotic medications during bleeding events were highly variable among providers (11 patients with nothing held, 1 apixaban held, 1 aspirin held, 1 clopidogrel held); however, no patients suffered carotid stent thrombosis.

CONCLUSIONS:

Bleeding complications are common within 30 days of TCAR and frequently result in unplanned hospital readmission and reintervention. There is significant provider-level variability in management of antithrombotic medications during these events. These data highlight need for evidence-based guidelines for the optimal pharmacologic strategy for patients post-TCAR who develop bleeding complications.

2024-12-31·ANNALS OF MEDICINE

Time-in-therapeutic-range defined warfarin and direct oral anticoagulants in atrial fibrillation: a Nationwide Cohort Study

Article

作者: Hartikainen, Juha ; Halminen, Olli ; Putaala, Jukka ; Kinnunen, Janne ; Teppo, Konsta ; Aro, Aapo L ; Lehtonen, Ossi ; Niemi, Mikko ; Mustonen, Pirjo ; Itäinen-Strömberg, Saga ; Lehto, Mika ; Tiili, Paula ; Airaksinen, K E Juhani ; Luojus, Alex ; Linna, Miika ; Haukka, Jari ; Kouki, Elis

BACKGROUND:

Little is known how individual time-in-therapeutic-range (TTR) impacts the effectiveness and safety of warfarin therapy compared to direct oral anticoagulants (DOACs) in patients with atrial fibrillation (AF).

OBJECTIVE:

To compare the effectiveness and safety of standard dose DOACs to warfarin in patients with AF, while categorizing warfarin treated patients into quartiles based on their individual TTR.

MATERIALS AND METHODS:

We conducted a nationwide study including all patients with new-onset AF between 2011 and 2018 in Finland. Hazard ratios (HR) were calculated using Cox regression analysis with the inverse probability of treatment weighted method to assess the risks of ischaemic stroke (IS), intracranial haemorrhage (ICH) and mortality for users of apixaban (n = 12,426), dabigatran (n = 4545), rivaroxaban (n = 12,950) and warfarin (n = 43,548).

RESULTS:

The median TTR for warfarin users was 72%. Compared to the second best TTR quartile (reference), the risk of IS was higher in the two poorest TTR quartiles, and lower in the best TTR quartile and on rivaroxaban [2.35 (95% confidence interval, 1.85-2.85), 1.44 (1.18-1.75), 0.60 (0.47-0.77) and 0.72 (0.56-0.92)]. These differences were non-significant for apixaban and dabigatran. HR of ICH was 6.38 (4.88-8.35) and 1.87 (1.41-2.49) in the two poorest TTR groups, 1.44 (1.02-1.93) on rivaroxaban, and 0.58 (0.40-0.85) in the best TTR group compared to the reference group. Mortality was higher in the two poorest TTR groups and lowest in the best TTR group.

CONCLUSIONS:

The outcome was unsatisfactory in the two lowest TTR quartiles - in half of the patients treated with warfarin. The differences between the high TTR groups and standard dose DOACs were absent or modest.

2024-12-31·RENAL FAILURE

Safety and efficacy of apixaban versus vitamin K antagonists in patients undergoing dialysis: a systematic review and meta-analysis

Review

作者: Zhang, Yifang ; Shen, Nannan ; Xie, Yanna ; Jiang, Jie ; Wang, Jialiang

BACKGROUND:

This review aims to evaluate the safety and efficacy of apixaban vs. vitamin K antagonists (VKAs) in patients on dialysis.

METHODS:

All types of studies published on PubMed, Embase, CENTRAL, and Web of Science up to 10 September 2023 and comparing outcomes of apixaban vs. VKA in dialysis patients were eligible.

RESULTS:

Two randomized controlled trials (RCTs) and six retrospective studies were included. Apixaban treatment was associated with significantly lower risk of major bleeding (RR: 0.61; 95% CI: 0.48, 0.77; I² = 50%) and clinically relevant non-major bleeding (RR: 0.82, 95% CI: 0.68, 0.98, I² = 9%) compared to VKA. Meta-analysis also showed that the risk of gastrointestinal bleeding (RR: 0.74, 95% CI: 0.64, 0.85, I² = 16%) and intracranial bleeding (RR: 0.64, 95% CI: 0.49, 0.84, I² = 0%) was significantly reduced with apixaban. Meta-analysis showed no difference in the risk of ischemic stroke (RR: 0.40, 95% CI: 0.06, 2.69, I² = 0%), mortality (RR: 1.26, 95% CI: 0.74, 2.16, I² = 94%) and recurrent venous thromboembolism (RR: 1.02, 95% CI: 0.87, 1.21, I² = 0%) between the two groups. Subgroup analysis of RCTs showed no difference in bleeding outcomes.

CONCLUSIONS:

Low-quality evidence from a mix of RCTs and retrospective studies shows that apixaban may have better safety and equivalent efficacy as compared to VKA in dialysis patients. Apixaban treatment correlated with significantly reduced risk of major bleeding and clinically relevant nonmajor bleeding in observational studies but not in RCTs. The predominance of retrospective data warrants caution in the interpretation of results.

595

项与阿哌沙班相关的新闻（医药）

2024-11-03

·赛柏蓝

跨国药企最新业绩：默沙东、辉瑞、诺华、礼来…

编者按：本文来自新康界，作者Dongyan；赛柏蓝授权转载，编辑yuki 01 默沙东： K药营收同比增近两成至216亿美元默沙东财报显示，今年第三季度其营收166.57亿美元，同比增长7%，其中制药业务收入同比增长8%至149.43亿美元。同期中国区业务收入9.96亿美元，于全球制药业务收入中的比重约为6.7%。 2024年前三季度，默沙东累计营收约为485.44亿美元，同比增长7%。但因第三季度业绩表现，默沙东下调了全年的收入指引，预计总营收会在636亿美元至641亿美元之间。在产品方面，仅“K药”即PD-1抗体Keytruda（帕博利珠单抗）前三季度就为默沙东贡献了216.46亿美元，同比增长18%，其中仅第三季度就收入74.29亿美元，同比增幅21%，保持了较高的增速。默沙东方面预计“K药”全年销售额或可超过290亿美元，甚至可能突破300亿美元。据悉，今年第三季度K药的增长主要源自于三阴乳腺癌（TNBC）、肾细胞癌（RCC）和非小细胞肺癌（NSCLC）等肿瘤早期适应症的渗透进一步提高。基于此前已获批的9项适应症，近期K药针对围手术期局部晚期头颈鳞癌的KEYNOTE-689研究也取得了积极结果，且默沙东已计划提交该适应症的上市申请。这有望成为Keytruda获批的第10项早期癌症适应症。但在HPV疫苗上，由于中国市场销售量下滑，默沙东的HPV疫苗Gardasil/Gardasil 9产品销售额在第三季度也同比下滑了10%，约为23.06亿美元。但在全球其他市场，该产品的销售却都有两位数的增长，因此默沙东对该产品组合到2030年实现超110亿美元销售额的目标仍充满信心。此外，在肺炎球菌感染领域，默沙东的15价肺炎球菌疫苗Vaxneuvance收入同比增长了13%至2.39亿美元。今年6月其还获批上市了21价肺炎球菌结合疫苗Capvaxive。心血管领域，默沙东的肺动脉高压新药Winrevair全球销售额达1.49亿美元，在美国肺动脉高压市场，第三季度接受Winrevair治疗的患者新增了约1700例。自该药上市以来，接受治疗的患者已超过3700例。 02 辉瑞：上调全年目标最高至640亿美元 2024年第三季度，辉瑞营业收入约为177.02亿美元，同比增长32%，除去Comirnaty和Paxlovid，其他产品的总收入为136亿美元，同比增长14%。今年前三季度，辉瑞总营收约为458.64亿美元，同比增长2%。辉瑞方面表示，基于今年以来的业绩增长态势，其决定将全年收入指引上调15亿美元，预计可达到610亿美元~640亿美元。分业务来看，2024年第三季度，辉瑞的肿瘤业务同比增长了31%，相关产品销售中，PARP抑制剂Talzenna同比增长77%，BCMAxCD3双抗Elrexfio环比增长了80%。此外，泌尿生殖系统肿瘤领域的销售贡献前三的药物中，CDK4/6抑制剂Ibrance（哌柏西利），第三季度销售额为10.87亿美元，但同比下降了12%。其次是雄激素受体信号抑制剂Xtandi（恩扎卢胺）、Nectin-4 ADC药物Padcev（维恩妥尤单抗），销售收入分别为5.06亿美元、4.09亿美元。另外，抗凝药Eliquis同期销售额约为16.17亿美元，同比增长9%；第三代ALK抑制剂Lorbrena（洛拉替尼）收入2.06亿，同比增长31%，BRAF/MEK抑制剂组合Braftovi/Mektovi收入1.73亿美元，同比增长32%。据悉，2023年底辉瑞曾以430亿美元的价格收购了Seagen公司，因此获得4款ADC药物，包括Padcev（维恩妥尤单抗）、Adcetris（维布妥昔单抗）、Tukysa（妥卡替尼）、Tivdak，2024年第三季度，该四款产品共为辉瑞带来了8.54亿美元的收入。 03 诺华：调高全年营收目标至两位数增长数据显示，2024年第三季度诺华收入128.23亿美元，同比增长10%，对应净收入约为31.85亿美元，同比增长121%。今年前9个月，诺华总收入约为371.64亿美元，同比增长11%，同期净收入约为91.19亿美元，同比增长62%。具体到不同业务及产品来看，诺华心血管-肾脏-代谢、免疫、神经科学和肿瘤业务前三季度的销售收入分别为61.73亿美元、68.86亿美元、34.59亿美元和108.08亿美元，同比均表现为增长，对应增幅分别为35%、22%、31%、15%。产品方面，前三个季度诺华心血管-肾脏-代谢领域的两款药物Entresto（沙库巴曲缬沙坦）和Leqvio（英克司兰）分别贡献了总计56.42亿美元和5.31亿美元的收入，同比分别增长了30%、130%。肿瘤领域产品中，CDK4/6抑制剂Kisqali（瑞波西利）前三季度的累计销售额达到21.31亿美元，同比增加了48%，占肿瘤业务的收入比重达到20%。此外，今年第三季度，Kisqali（瑞波西利）在美国亦新增了两项适应症，包括①联合芳香化酶抑制剂作为初始内分泌疗法治疗HR+/HER2-的晚期或转移性乳腺癌成人患者，或联合氟维司群治疗内分泌治疗后出现病情进展的上述人群的患者；②联用芳香化酶抑制剂辅助治疗HR+/HER2-且复发风险高的II期和III期早期乳腺癌（EBC）患者，包括淋巴结阴性（N0）患者。另外一款重磅肿瘤产品Pluvicto前三季度收入10.41亿美元，同比增加47%。目前，Pluvicto可用于三线治疗PSMA阳性转移性去势抵抗性前列腺癌（mCRPC），另外诺华已提交Pluvicto用于二线治疗PSMA阳性mCRPC的上市申请。该适应症获批后，Pluvicto的全年销售额有望达到新的高度。鉴于目前的业绩表现，诺华表示，2024年整体业绩展望将从原先的高个位数增长上调至低两位数增长。 04 礼来：替尔泊肽全年收入或超160亿美元今年第三季度，礼来营收约为114.4亿美元，净利润约为9.7亿美元，因该业绩低于市场预期，礼来决定将今年的全年营收预期上限从466亿美元稍下调至460亿美元。 2024年前三季度礼来整体营业收入为315亿美元，同比增长27%，净利润61.8亿美元。具体产品来看，礼来的重磅产品替尔泊肽前三季度合计销售额达到了110亿美元，其中替尔泊肽降糖版Moujaro销售额80.10亿美元，去年同期为29.58亿美元，替尔泊肽减重版Zepbound销售额30.18亿美元，预计替尔泊肽产品全年收入超过160亿美元。仅从第三季度来看，降糖版Moujaro销售收入约为31.1亿美元，较去年同期实现翻倍增长，但减重版Zepbound销售收入12.6亿美元，低于市场预期的17亿美元，对此礼来方面认为是由于产能受限，因此宣布将持续拓展产量。管线方面，第三季度财报还显示，礼来停止了三条管线的研发，包括口服小分子IL-17a抑制剂DC-806、PD-1激动剂抗体Peresolimab以及一款用于心血管疾病的APOC3 siRNA。其中口服小分子IL-17a抑制剂DC-806是礼来2023年刚刚以24亿美元的高价收购所得，但当时收购的还有改善活性与药代的DC-853，一款Fast-follow药物，此次停止DC-806的研发后，礼来将全力支持DC-853的研发。另外一款被停止研发的Peresolimab，是目前全球进展最快的PD-1激动剂抗体，2023年礼来曾公布其用于治疗难治性类风湿关节炎（RA）的2a期临床试验结果阳性。据悉，默沙东、BMS、吉利德等MNC都曾通过收并购的方式获得过PD-1激动剂抗体，但大多数都没有更多新的进展或宣告终止开发。 05 渤健：前三季营收下滑3%至72亿美元财报显示，2024年第三季度渤健营收约为24.66亿美元，同比减少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，环比第二季度增长了66%，其中美国市场的销售额约3900万美元。其他产品中，多发性硬化症领域第三季度贡献营收10.54亿美元，同比减少9%；罕见病领域实现营收4.95亿美元，同比表现为增长10%；产后抑郁药物ZURZUVAE（舒拉诺龙）第三季度的收入则约为2200万美元。整体而言，今年1-9月，渤健总营收72.21亿美元，同比下滑3%，其中产品收入53.81亿美元。同时，渤健还提高了2024年的全年财务指引，从增长9%提高至增长11%，核心药品的收入预计会与2023年的大致持平。 END 内容沟通：郑瑶（13810174402）左下角「关注账号」，右下角「在看」，防止失联

财报疫苗

2024-11-01

·BioSpace

BMS Delivers Q3 Beat, Raises 2024 Guidance Amid Strong Demand for Legacy and Newer Drugs

iStock, arlutz73 Bristol Myers Squibb’s third-quarter results benefited from sales of its legacy brands Eliquis and Revlimid, as well as growth portfolio products such as Abecma, Breyanzi and Reblozyl. Bristol Myers Squibb on Thursday touted strong year-over-year growth in the third quarter of 2024, with sales handily beating the consensus estimate driven by its legacy and newer products. On the strength of the Q3 performance, BMS raised its full-year revenue guidance, now expecting a year-over-year increase of around 5%—up from its previous forecast of the upper end of low-single-digit growth. The outlook for the company’s full-year diluted earnings-per-share (EPS) was also lifted to $0.75 to $0.95, from the previous range of $0.60 to $0.90. “Our overall business mix is beginning to transform as our growth portfolio is becoming a bigger component,” CEO Christopher Boerner said during an investor call on Thursday, touting the combination of its pipeline—which is approaching several “near-term catalysts”—and a “disciplined focus on expense management.” These factors, Boerner said, are key to the company’s “focus on executing in the near term while laying the groundwork for long-term sustainable growth.” In Q3, BMS reported total global revenues of $11.9 billion–8% year-over-year growth at constant currencies—and a 6% beat versus the consensus estimate of $11.3 billion. In an investor note, William Blair analyst Matt Phipps credited BMS’ strong quarter to the reliable performance of its legacy brands—including Revlimid and Eliquis—and the “traction” of its growth portfolio brands such as Breyanzi, Abecma and Reblozyl, which “all beat consensus estimates.” Truist Securities analyst Srikripa Devarakonda in an investor note said the multiple myeloma drug Revlimid declined “less than anticipated.” Its sales dipped 1% in the quarter to $1.4 billion but still exceeded the consensus of $1.1 billion. The blood thinner Eliquis continues to be BMS’ top-performing asset, jumping 11% year-over-year to bring in just over $3 billion in Q3. BMS’ earnings call was primarily focused on its newly approved schizophrenia therapy Cobenfy, which won the FDA’s nod in September 2024 . Boerner said the drug had “multibillion-dollar potential” and will help the company accelerate its growth, though the company’s optimism appeared to be largely measured. BMO Capital Markets analyst Evan Seigerman in an investor note said that “while we appreciate conservatism in neuropsych, management commentary has been somewhat muted around revenue expectations,” particularly as “launch is expected to be a slow build in schizophrenia.” By contrast, Seigerman expects Alzheimer’s psychosis as a stronger opportunity for Cobenfy “in terms of sentiment.” Cobenfy is currently in Phase III development for this indication. “While we are encouraged by Bristol’s progress in the quarter on top line and expenses, the transformative change Bristol needs will come from its pipeline,” Seigerman wrote. Consensus peak sales estimate for Cobenfy is $5.4 billion. BMS expects to see a “sales ramp” for Cobenfy starting in the second half of 2025, following broad access in Medicare and Medicaid patients, Chief Commercialization Officer Adam Lenkowsky said during Thursday’s investor call.

临床3期

2024-10-31

·echemi

Pharmaceutical Giants Challenge the U.S.'s First Mandatory Drug Price Negotiation Law, Claiming $6 Billion!

Legal advisers for AstraZeneca, Bristol Myers Squibb and Johnson & Johnson filed a petition on Wednesday with the federal appeals court in Philadelphia to rehear a lawsuit The lawsuit challenges the first law in US history to force drug companies to negotiate drug prices with Medicare, the government insurance program. The health insurance program benefits about 66 million Americans. In the initial negotiations, Astrazeneca's diabetes drug Farxiga, Bristol-Myers Sfubb's anticoagulant Eliquis and Janssen's anticoagulant Xarelto were selected as among 10 drugs subject to price negotiations, and their prices were subsequently reduced by 56% to 68%. The new pricing, which would begin in 2026, is expected to save Medicare about $6 billion in the first year. The drug companies argue that the program, part of the Inflation Reduction Act, constitutes a gratuitous expropriation of their property in violation of the U.S. Constitution. Earlier, federal district courts in Delaware and New Jersey dismissed the companies' lawsuits. Yaakov Roth of Jones Day, representing Bristol-Myers, argued in arguments Wednesday to a three-judge panel of the 3rd U.S. Circuit Court of Appeals that the law does not give drug companies leeway to negotiate and instead threatens them with steep fines or withdrawal from Medicare. Bring the company to heel. Medicare accounts for almost half of the prescription drug market. Catherine Padhi, a lawyer for the Justice Department, responded that the government had the power to use its purchasing power to achieve its goals and offered the plaintiffs "a very favorable deal." Mr. Janssen's lawyer, Kevin King of Covington & Burling, argued that the law violated the company's First Amendment right to free speech by requiring it to accept the "highest fair price," even if it deemed the price unfair. "The government cannot force regulated parties to express the government's preferred message," King said. Padhi countered that "maximum fair price" is a "statutory term" and does not involve a subjective value judgment. The panel, composed of circuit judges Thomas Hardiman, Peter Phipps and Arianna Freeman, did not explicitly indicate its intention to rule. During questioning, Judge Hardiman suggested that the plan could be seen as the government using its "leverage" to force drugmakers to give up their property. But he also noted that drugmakers were trying to enjoy the benefits of both the government's "massive purchasing power" and "free market pricing" while the program was designed to stop "the federal budget deficit from spiraling out of control." So far, drugmakers' legal challenges to pricing plans have been largely unsuccessful. But in September of this year, The Fifth U.S. Circuit Court of Appeals in Texas reinstated a lawsuit brought by the Pharmaceutical Research and Manufacturers of America, the largest U.S. pharmaceutical industry lobbying group, and other groups. The cases included Astrazeneca v. Becerra (case No. 24-1819) and Myers Squibb et al. V. Becerra (case No. 24-1820), both before the United States Court of Appeals for the Third Circuit. Astrazeneca was represented by Kate Stetson of Hogan Lovells; Bristol-myers was represented by Yaakov Roth of Jones Day; Janssen was represented by attorney Kevin King.

专利侵权

100 项与阿哌沙班相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03213	阿哌沙班	B01AF02	DB06605

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
复发性深静脉血栓形成	欧盟	Accord Healthcare SLU	2020-07-23
复发性深静脉血栓形成	冰岛	Accord Healthcare SLU	2020-07-23
复发性深静脉血栓形成	列支敦士登	Accord Healthcare SLU	2020-07-23
复发性深静脉血栓形成	挪威	Accord Healthcare SLU	2020-07-23
血栓形成	中国	Bristol-Myers Squibb/Pfizer EEIG	2013-01-22
缺血性卒中	日本	Bristol-Myers Squibb KK	2012-12-25
全身性栓塞	澳大利亚	Bristol Myers Squibb Co.	2011-07-21
心房颤动	欧盟	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18
心房颤动	冰岛	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18
心房颤动	列支敦士登	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18
心房颤动	挪威	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18
栓塞	欧盟	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18
栓塞	冰岛	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18
栓塞	列支敦士登	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18
栓塞	挪威	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18
肺栓塞	欧盟	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18
肺栓塞	冰岛	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18
肺栓塞	列支敦士登	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18
肺栓塞	挪威	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18
脑卒中	欧盟	Bristol-Myers Squibb/Pfizer EEIG	2011-05-18

未上市

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适应症	最高研发状态	国家/地区	公司	日期
慢性肢体威胁性缺血	临床3期	巴西	Wyeth AB	2020-01-09
脑梗塞	临床3期	美国	Bristol Myers Squibb Co.	2018-12-19
脑梗塞	临床3期	美国	Pfizer Inc.	2018-12-19
认知功能障碍	临床3期	美国	Pfizer Inc.	2018-12-19
认知功能障碍	临床3期	美国	Bristol Myers Squibb Co.	2018-12-19
肿瘤	临床3期	奥地利	Bristol Myers Squibb Co.	2018-10-11
肿瘤	临床3期	比利时	Bristol Myers Squibb Co.	2018-10-11
肿瘤	临床3期	加拿大	Bristol Myers Squibb Co.	2018-10-11
肿瘤	临床3期	法国	Bristol Myers Squibb Co.	2018-10-11
肿瘤	临床3期	希腊	Bristol Myers Squibb Co.	2018-10-11

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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


NCT04974684 (CTgov)	N/A	-	45	Apixaban (Apixaban Alone Group)	繭壓淵網製願衊構膚鬱(鹽淵網鹹積積鬱襯網廠) = 膚獵膚夢構鬱觸衊選築齋選糧鹹餘繭夢築襯顧 (壓廠簾選願顧鑰夢鹹鑰, 觸窪餘鑰遞網鹹獵簾鹹 ~ 鬱夢憲憲醖夢蓋衊艱觸) 更多	-	2024-08-20
				Apixaban+Aspirin (Apixaban + Aspirin Group)	繭壓淵網製願衊構膚鬱(鹽淵網鹹積積鬱襯網廠) = 壓繭繭襯餘鑰構繭鹽襯齋選糧鹹餘繭夢築襯顧 (壓廠簾選願顧鑰夢鹹鑰, 膚憲簾壓壓餘餘壓顧網 ~ 觸膚鑰憲選鏇壓製鹽鏇) 更多
NCT01938248 (ARTESiA, Pubmed)	临床4期	脑卒中 \| 栓塞和血栓形成 \| 心房颤动	-	Apixaban	網願襯構艱積選窪窪構(鏇願糧觸網顧築衊鹹膚) = 蓋憲選襯築淵窪醖觸顧壓築鏇鏇餘製衊鹽簾鬱 (蓋淵顧鑰選夢網獵選夢 )	积极	2024-07-23
				Aspirin	網願襯構艱積選窪窪構(鏇願糧觸網顧築衊鹹膚) = 餘醖壓鹹衊窪觸鬱製夢壓築鏇鏇餘製衊鹽簾鬱 (蓋淵顧鑰選夢網獵選夢 )
ASCO2024	N/A	多发性骨髓瘤 IMiD treatment	448	Apixaban	鹽餘膚襯襯膚壓積顧壓(選遞襯選築廠壓築鏇鹽): HR = 0.7 (95% CI, 0.56 ~ 0.88) 更多	积极	2024-05-24
				Warfarin
SAVED and IMPEDE VTE (ASCO2024)	N/A	多发性骨髓瘤 SAVED score \| IMPEDE score	347	Aspirin	選構獵壓糧鏇醖獵窪夢(鑰構構餘積遞鹹鑰獵網) = 範顧壓淵獵壓膚壓構獵鹽積積膚願鹹夢鏇鹹繭 (鏇鬱齋鹹積餘鹽鬱構願 )	积极	2024-05-24
				Apixaban	選構獵壓糧鏇醖獵窪夢(鑰構構餘積遞鹹鑰獵網) = 廠築醖蓋選網醖願積壓鹽積積膚願鹹夢鏇鹹繭 (鏇鬱齋鹹積餘鹽鬱構願 )
EHA2024	N/A	多发性骨髓瘤	23	Low-dose apixaban (2.5 mg bd)	觸繭構蓋繭艱觸鏇觸廠(觸顧顧範鹽獵鹽築蓋構) = 餘壓簾觸積鑰鬱簾築壓壓願繭壓襯鏇蓋獵觸蓋 (構膚夢網獵遞壓淵積顧 ) 更多	积极	2024-05-14
NCT04865978 (DOAC LVAD, Pubmed)	临床2期	一线	30	Warfarin therapy	醖鹽顧蓋製鏇蓋鏇製餘(窪糧襯廠鬱築鏇繭選製) = 2 patients (14%) receiving warfarin experienced major bleeding from gastrointestinal sources 構衊選蓋膚齋繭鹽壓鹹 (製願積襯觸壓鑰鏇壓艱 )	积极	2024-05-07
AUA2024	N/A	-	-	Apixaban 2.5mg	夢夢獵餘繭糧簾鏇網衊(積糧憲糧鹹餘糧築廠衊) = 範鬱廠繭艱構鏇築範鬱願齋衊艱簾遞觸製鬱窪 (憲憲憲蓋網積製鬱艱蓋 ) 更多	积极	2024-05-01
				Enoxaparin 40mg	夢夢獵餘繭糧簾鏇網衊(積糧憲糧鹹餘糧築廠衊) = 築鹽衊衊積積鑰壓鑰糧願齋衊艱簾遞觸製鬱窪 (憲憲憲蓋網積製鬱艱蓋 ) 更多
NCT03080883 (EVE, Pubmed) 人工标引	临床3期	静脉血栓栓塞	360	Apixaban 2.5 mg	鹹鹹鏇齋窪窪蓋繭構鹽(鬱積選網範顧範窪鹹網) = 夢顧鹽顧選獵艱鬱觸鏇構築襯醖鹹糧觸齋膚顧 (夢齋鹹襯鹹繭遞艱顧獵 ) 更多	不佳	2024-03-25
				Apixaban5 mg	鹹鹹鏇齋窪窪蓋繭構鹽(鬱積選網範顧範窪鹹網) = 糧構鹹淵築築艱構選襯構築襯醖鹹糧觸齋膚顧 (夢齋鹹襯鹹繭遞艱顧獵 ) 更多
NCT04142658 (CTgov)	临床3期	主动脉瓣狭窄 \| 主动脉瓣疾病 \| 主动脉瓣关闭不全	863	On-X Aortic Mechanical Valve+Apixaban 5 MG (Apixaban)	製襯餘蓋艱繭膚鑰鏇遞(獵憲構鑰淵積廠範鬱顧) = 願積膚艱膚蓋積衊構鏇窪鏇齋積糧鹽齋範繭簾 (積醖鑰壓鏇簾觸衊觸願, 淵遞築醖淵選襯願積膚 ~ 淵鹽鑰襯淵廠獵廠醖壓) 更多	-	2024-03-20
				On-X Aortic Mechanical Valve+Warfarin (Warfarin)	製襯餘蓋艱繭膚鑰鏇遞(獵憲構鑰淵積廠範鬱顧) = 襯壓壓襯衊衊淵膚鬱艱窪鏇齋積糧鹽齋範繭簾 (積醖鑰壓鏇簾觸衊觸願, 餘糧齋構蓋鏇醖餘願願 ~ 簾糧衊鬱淵窪鑰構構膚) 更多
NCT01938248 (ARTESIA, Pubmed \| Br Dent J) 人工标引	临床4期	心房颤动	4,012	Apixaban	憲鏇築膚願醖淵壓簾製(構壓鹹網壓遞顧觸廠鏇) = 遞艱繭積憲廠膚艱壓鬱範築積積選艱遞膚艱選 (製鬱鏇鏇簾簾鬱窪窪糧 ) 更多	积极	2024-01-11
				Aspirin	憲鏇築膚願醖淵壓簾製(構壓鹹網壓遞顧觸廠鏇) = 鹹蓋艱淵構餘膚顧選蓋範築積積選艱遞膚艱選 (製鬱鏇鏇簾簾鬱窪窪糧 ) 更多