Randomized, Double-blind, Placebo-Controlled, Multiple-Attack Study With an Open-Label Extension to Evaluate the Efficacy, Safety, Tolerability, and the Consistency of Effect of Atogepant for the Acute Treatment of Migraine (ECLIPSE)

A migraine attack is a moderate or severe headache that usually occurs on one side of the head and is often accompanied by throbbing, sensitivity to light, sensitivity to sound, nausea, or other symptoms. The main goal of the study is to see if atogepant is effective, safe, and well-tolerated in treating migraine attacks quickly.
Atogepant is a medicine currently approved for the preventive treatment of migraine in adults and has been shown to be effective and well tolerated when taken daily to prevent migraine attacks. This study includes double-blind phase means that neither the participants nor the study doctors know who is given which study treatment (atogepant or placebo) followed by an open-label phase meaning that both participants and study doctors know which study treatment is given. All participants will receive atogepant during the open-label part of the study. This study will include 1300 participants aged 18-75 years with a history of migraine at approximately 160 sites across the world.
All participants will receive both atogepant and placebo to treat qualifying migraines. At the start of the study, participants will be randomized to 1 of 4 dosing sequences to determine when they will receive atogepant and when they will receive placebo during the study. After treating 4 qualifying migraine attacks, participants will receive open-label atogepant for any additional migraine attacks they have until the end of the study (Week 24).
There may be a bigger responsibility for participants in this study than there would be in participants receiving standard of care treatment. participants will attend regular visits during the study at a hospital or clinic, as well as telephone visits, and the effects of treatment will be checked by completion of questionnaires in an electronic diary, medical assessments, blood tests, and checking for side effects.

开始日期2024-04-30

申办/合作机构

AbbVie, Inc.

NCT06136442 / Not yet recruitingN/A

Atogepant in Real Life in Italy

Atogepant is an oral, small-molecule, calcitonin gene-related peptide (CGRP) receptor antagonist that has been approved for the preventive treatment of episodic and chronic migraine (>= 4 monthly migraine days) with or without medication overuse.

开始日期2024-04-09

申办/合作机构

IRCCS San Raffaele Roma Srl

NCT06212661 / Enrolling by invitationN/A

Migraine Medication Effects on Urinary Symptoms

A prospective observational cohort trial to study the effects of CGRP inhibitors (CGRPi) on lower urinary tract symptoms (LUTS) and bladder/pelvic pain. Candidates for either CGRPi or an alternative therapy for refractory migraines (OnabotulinumtoxinA (BoNTA) extracranial muscle injections) with baseline LUTS will be recruited. The investigators will assess LUTS and pelvic pain using validated symptom and quality-of-life questionnaires, pretreatment and at 3 months post-treatment follow-up, comparing change in symptoms based on treatment received.

开始日期2024-03-01

申办/合作机构

The Cleveland Clinic Foundation

100 项与阿托吉泮相关的临床结果

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100 项与阿托吉泮相关的转化医学

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100 项与阿托吉泮相关的专利（医药）

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项与阿托吉泮相关的文献（医药）

2024-02-21·Clinical drug investigation

Cost-Effectiveness Evaluation of Oral CGRP Antagonists, Atogepant and Rimegepant, for the Preventative Treatment of Episodic Migraine: Results from a US Societal Perspective Model.

Article

作者: Ryan Thaliffdeen ; Anthony Yu ; Karen Rascati

BACKGROUND AND OBJECTIVES:

Two oral calcitonin gene-related peptide (CGRP) antagonists, atogepant and rimegepant, were approved in 2021 for the preventive treatment of episodic migraine (EM), yet no formal cost-effectiveness analysis has been published. The objective of this study was to evaluate the cost-effectiveness of atogepant 60 mg and rimegepant 75 mg compared with placebo.

METHODS:

A decision tree model was constructed over a 1-year time horizon from a US societal perspective. Patient cohorts were simulated using baseline and change from baseline monthly migraine days (MMDs) reported in the trials to incorporate responder rates and within patient response into the model. Due to heterogeneity between the trial populations, each medication was compared with its respective trial's placebo group. Direct healthcare resource costs, productivity costs, acute medication costs, and quality-of-life values were obtained from the literature.

RESULTS:

The atogepant cohort experienced an incremental increase in healthcare plus productivity costs of $11,978 when compared with placebo, with a gain of 0.026 quality-adjusted life-years (QALYs). This yielded an incremental cost-effectiveness ratio (ICER) of more than $450,000/QALY. The rimegepant cohort experienced an incremental increase of $21,692 when compared with placebo, with a gain of 0.024 QALYs. This yields an ICER of more than $890,000/QALY when comparing rimegepant with placebo. Cost savings between atogepant and atogepant placebo were greatest with respect to acute medication costs at $735 of savings over 1 year, followed by savings of $135 for healthcare resource utilization and $34 for productivity costs. A similar relationship was seen between rimegepant and rimegepant placebo. One-way deterministic sensitivity analysis found that monthly acquisition costs of atogepant and rimegepant had the largest impact on the ICER, respectively.

CONCLUSIONS:

Atogepant and rimegepant were both unable to meet generally accepted cost-effectiveness thresholds < 150,0000/QALY. Additional studies are needed to better guide decision making regarding oral CGRPs' place in therapy.

2024-02-13·The Lancet. Neurology

Safety and efficacy of atogepant for the preventive treatment of episodic migraine in adults for whom conventional oral preventive treatments have failed (ELEVATE): a randomised, placebo-controlled, phase 3b trial.

Article

作者: Cristina Tassorelli ; Krisztián Nagy ; Patricia Pozo-Rosich ; Michel Lanteri-Minet ; Sara Sacco ; Tomáš Nežádal ; Hua Guo ; Rosa De Abreu Ferreira ; Giovanna Forero ; Joel M Trugman

BACKGROUND:

Atogepant, an oral calcitonin gene-related peptide receptor antagonist, has been approved for the preventive treatment of migraine, but its efficacy and safety in people who have been failed by conventional oral preventive migraine treatments has not yet been evaluated in a dedicated clinical trial. The ELEVATE trial evaluated the safety, tolerability, and efficacy of atogepant for the preventive treatment of episodic migraine in participants for whom two to four classes of conventional oral preventive treatments have failed.

METHODS:

ELEVATE was a randomised, double-blind, placebo-controlled, parallel-group, phase 3b trial done at 73 sites in Canada, the Czech Republic, Denmark, France, Germany, Hungary, Italy, the Netherlands, Poland, Russia, Spain, the UK, and the USA. Adults (18-80 years) with episodic migraine who had previously been failed by two to four classes of conventional oral treatments for migraine prevention were randomly assigned (1:1) using interactive web response technology to oral atogepant 60 mg once a day or placebo, stratified by baseline monthly migraine days, number of treatment classes participants have been failed by, and region. The primary endpoint was change from baseline in mean monthly migraine days across the 12-week treatment period in the off-treatment hypothetical estimand (OTHE) population, which included participants in the safety population (all participants who received ≥1 dose of study intervention) who had evaluable data available for the baseline period and for one or more of the 4-week post-baseline periods (whether on treatment or off treatment). The primary endpoint was analysed using a mixed model for repeated measures and a fixed-sequence procedure was used to control for multiple comparisons. The trial is registered with ClinicalTrials.gov (NCT04740827) and EudraCT (2019-003448-58), and is completed.

FINDINGS:

Between March 5, 2021, and Aug 4, 2022, 540 participants were screened, 315 were randomly assigned, and 313 participants (280 [89%] female, 33 [11%] male, and 300 [96%] White) received at least one dose of study intervention. In the OTHE population, which comprised 309 participants (155 assigned to placebo and 154 to atogepant), least squares mean changes from baseline in monthly migraine days across 12 weeks were -1·9 (SE 0·4) with placebo and -4·2 (0·4) with atogepant (least squares mean difference -2·4, 95% CI -3·2 to -1·5; adjusted p<0·0001). The most common treatment-emergent adverse event with atogepant was constipation in 16 (10%) of 156 participants (vs four [3%] of 157 for placebo). Serious adverse events occurred in four [3%] of 156 participants in the atogepant group vs none in the placebo group, and treatment-emergent adverse events resulting in treatment discontinuation occurred in three [2%] in the atogepant group vs two [1%] in the placebo group.

INTERPRETATION:

Atogepant 60 mg once a day was safe, well tolerated, and showed significant and clinically relevant reductions in mean monthly migraine days compared with placebo across 12 weeks in patients with episodic migraine who had previously been failed by two to four classes of conventional oral preventive treatments. Atogepant might be an effective preventive treatment option for patients in this difficult-to-treat population.

FUNDING:

Allergan (now AbbVie).

2024-02-13·Journal of the Chinese Medical Association : JCMA

Update on gepants for the treatment of chronic migraine.

Review

作者: Yu Aoh ; Tsung-Wei Hou ; Cheng-Chia Yang ; Ching-Mao Chang ; Shih-Pin Chen ; I-Ju Tsai ; Chin-Wen Cheng ; Chun-Pai Yang

Chronic migraine (CM) is a profoundly debilitating condition that has detrimental clinical and social outcomes. Over the past two decades, novel small-molecule calcitonin gene related peptide (CGRP) receptor antagonists, known as gepants, and CGRP monoclonal antibodies (mAbs) have been developed, ushering in a new era of migraine-specific treatment. In this review, we discuss the literature investigating the role of gepants for the treatment of CM. Numerous completed and ongoing clinical studies have conclusively demonstrated the safety, tolerability, and efficacy of several gepants for the acute treatment of migraine. However, preventive trials involving gepants have focused on patients with episodic migraine, with atogepant being the only gepant approved for CM prevention by the US Food and Drug Administration at the time of writing. Although some preliminary positive results have been reported, further research is still required to achieve additional advancements in the future. In summary, the effectiveness of gepants for treating individuals with CM are highly expected. This review highlights the development and current progress of gepants for the treatment of CM, focusing both on their role as acute abortive agents and preventive measures and on their concomitant use with other antimigraine medications, such as CGRP mAbs or triptans.

116

项与阿托吉泮相关的新闻（医药）

2024-04-08

·GBIHealth

年度收藏：跨国药企核心产品管线布局、研发进度-2023 H2（上篇）

引文跨国药企掌握着全球医药行业最强大的网络资源和决策智慧，他们用真金白银投票选择的方向有更大概率是较符合技术进步规律的（当然这既不意味着他们的决策一定正确、也不意味着这些决策能够被有效执行），通过对他们所有核心产品管线进行系统梳理并定期更新，就有助于我们系统性地了解在大药企自己的话语体系里，究竟哪些方向是在做的、有进展的、值得期待的，从而可以对判断到底什么是所谓“主流技术方向”有更全面直观的依据。本篇将为大家梳理礼来、诺和诺德、强生、默沙东、艾伯维五家企业的管线情况。在GLP-1横扫一切的强势驱动下，无论是业绩和市值，还是各自的产品布局，全球大药企都在经历深刻的变局，甚至可以说进行了颠覆性的重排，仅是下面这张摘要图与半年前相比就有不小的差异。- 左右滑动查看更多 -Lilly礼来礼来在2023年一骑绝尘成功登顶全球药企市值之冠，更夸张的是在2024年刚过两个月又从5,000多亿飚到7,000多亿，眼看就要冲着人类有史以来第一个万亿市值药企的壮举而去了。不过，这疯狂的市值还是有大幅预支未来成长之嫌，毕竟过往业绩虽然表现不俗，但也绝不是成倍的爆发式增长，且看未来是“预支”还是“透支”了。当然，礼来的业绩成长本身确实非常震撼，Tirzepatide在第一个完整销售年度豪取53亿美元、其中Q4单季24亿，在这种震古烁今的爬坡速度驱动下，礼来整体收入额一举从2022年的285亿跃升到2023年的341亿，而且仍处在继续向上跃升的过程中，2024年的业绩指引就是收入提升到410亿左右。- 左右滑动查看更多 -管线的攻城略地仍在发力：在万众瞩目的减肥线上，Tirzepatide肥胖适应症终于获批、并公布了MASH二期临床topline数据，Retatrutide和Orforglipron的多个三期临床先后启动；自免线上，Mirikizumab终于获批、并公布了CD三期临床结果，而Lebrikizumab却收到了FDA的CRL；Donanemab上市却意外地再次被推迟；肿瘤线上，Pirtobrutinib获批CLL/SLL适应症，从POINT收购来的核药PNT-2002也加入管线。- 左右滑动查看更多 -NOVO NORDISK诺和诺德诺和诺德在这波GLP-1狂潮中，市值从1,000亿飙升到接近6,000亿，与礼来呈一时瑜亮之势，在公司创立百年之际达到了可以说是从未有过的高度。看诺和诺德这十年以来的业绩成长，也确实配得上市值的提升。Semaglutide的三个品牌合计在2023年带来了近220亿美元销售额，不过近几个季度在GLP-1中的处方量市场份额已经开始走平，Tirzepatide迅速爬坡带来的竞争压力肉眼可见。- 左右滑动查看更多 -产能制约依然是严重瓶颈，特别是从2023年5月之后低剂量的供应出现明显的受限、以至于对国际市场还会实施供应量限制，从2024年1月开始逐渐增加供应能力，比起半年报时候“will remain restricted”的表述来看应该是有所缓解；产能扩建则继续加码，连续三年持续Capex翻倍的计划。- 左右滑动查看更多 -最重要的研发进展当然还属Semaglutide获批用于心血管风险保护、公布慢性肾病和HFpEF等三期临床结果，以及刚刚公布Amycretin一期的惊艳减重数据；其他值得关注的进展包括高草酸尿症RNAi疗法Nedosiran终于获批，Icosema完成三期临床，从中国药企KBP收购高血压资产等；瘦身也在持续，两个罕见病疗法Belcesiran和Eclipse先后消失在管线中。- 左右滑动查看更多 -J&J强生强生虽然业绩持续稳定，但市值近期下滑到4,000亿以下，被礼来与诺和诺德连续超车。强生医药板块的业绩在大药企中还是相当稳健，其中Ustekinumab和Daratumumab两大引擎的驱动力都非常充足，Guselkumab和Macitentan+Selexipag也表现不俗，但Ibrutinib、Infliximab、Abiraterone、Paliperidone等曾经的超重磅品种确实老态渐显。研发方面最突出的依然是在多发性骨髓瘤领域的“遮断性”优势，不过近期高歌猛进似有放缓，主要进展包括：Talquetamab获得欧盟批准；Teclistamab两周一次剂型获批；Daratumumab皮下剂型公布一线可移植MM患者的三期临床数据；Cilta-cel二线MM适应症获得欧盟积极意见；BCMA/CD3/GPRC5D三抗JNJ-5322公布一期临床数据。其他值得关注的进展包括：2019年从Taris收购来的新型膀胱内药物输送系统TAR-200/201分别公布了二期和一期数据；FcRn单抗Nipocalimab公布二期RA数据并获得FDA突破性认证；FGFR抑制剂Erdafitinib获得FDA完全批准并公布三期临床THOR2研究结果。管线新陈代谢正在进行，从收购Ambrx获得ARX-517/788等ADC资产，而RPGR AAV从管线中被拿掉。- 左右滑动查看更多 -MSD默沙东默沙东近期收入端依然表现稳健，K药仍在增长并稳住了药王地位（虽然刚上位没多久），HPV疫苗也增速不减，这两大定海神针填上了Molnupiravir急速缩水以及Sitagliptin专利悬崖带来的缺口，市值还是逼近3,000亿。研发进展中依然一大半都还是围绕K药的各种扩适应症和联用方案，近期主要进展包括：围手术期NSCLC的三期OS结果；获批1L HER2阴性胃癌和胆管癌等适应症；与mRNA-4157合作启动NSCLC辅助治疗的三期临床。其他重点值得关注的包括：与第一三共达成重大合作获得多个ADC管线，其中U3-1402已提交上市申请；HIF2α抑制剂Belzutifan获批2L RCC适应症；TIGIT单抗Vibostolimab公布与K药联用的NSCLC二期数据；肺炎疫苗V116和PAH药物Sotatercept提交上市申请；从科伦引进的TROP2 ADC、BTK C481S抑制剂Nemtabrutinib、CYP11A1抑制剂和LSD1抑制剂MK-5684Bomedemstat等启动三期临床。此外，收购Harpoon获得的DLL3/CD3/Albumin三抗加入管线，而P2X3慢性咳嗽药物Gefapixant则再次收到CRL。- 左右滑动查看更多 -Abbvie艾伯维2023年以来，Adalimumab和Ibrutinib两大超重磅受竞争者的挤压销售额开始出现大幅下滑，所幸Risankizuma、Upadacitinib、Venetoclax、Cariprazine几个新生代贡献一定的增量，整体业绩才算没有太崩坏，因此市值基本上还是稳定在2,500亿上下。眼看着业绩支撑轴在发生更迭，艾伯维将Risankizumab和Upadacitinib的峰值预期提高到170亿和100亿以上，试图再造一个Adalimumab时代的免疫帝国。- 左右滑动查看更多 -管线方面同样是在经历重心的迁移：免疫线逐渐收缩到围绕现有重磅的适应症扩展，近期包括Risankizumab公布与Ustekinumab在CD适应症的头对头三期临床结果、Upadacitinib公布白癜风二期临床结果，此外IL-1α/β双抗Lutikizumab公布化脓性汗腺炎二期临床结果，另有SCF248、IL-2、GLP-2等新机制加入管线；肿瘤线进展包括收购Immunogen并获得多个ADC资产，CD20×CD3双抗Epcoritamab获得欧盟批准并向FDA提交末线FL的上市申请，Teliso-V公布NSCLC二期临床数据，同时补充了大批新项目进入管线；神经/精神线进展较多，帕金森复方药物ABBV-951提交上市申请，偏头痛药物Atogepant和Ubrogepant分别提交预防适应症的上市申请和公布前兆适应症的三期临床数据，此外通过87亿巨额收购Cerevel补充多个AD/PD管线。- 左右滑动查看更多 -数据声明本文选取截至2023年12月31日市值超过1,000亿美元的制药企业，共11家。已上市产品包括收入贡献较大的（年销售额10亿美元以上）、尚在增长或稳定期的（获批10年以上的基本不考虑）和仍在积极开发阶段的（正在进行重要适应症扩展的临床试验）；临床在研管线以年报季报的研发进度更新章节、研发日及重要会议展示材料和公司日常信息披露等取并集，故可以理解为公司自己认为当前优先级较高的管线，而并不覆盖全体管线。主要梳理信息包括近几个季度的市值和收入利润变化（多主业公司只取制药板块）、半年内最重要的审批进展和临床数据发布、以及未来近期的重要里程碑。\ | /★联系我们投稿 | 发稿 | 媒体合作▶ sylvia.hua@generalbiologic.com数据库 | 咨询服务 | 资讯追踪▶ 点击左下“阅读原文”完成表单填写点击阅读原文订阅全球行业新闻

临床3期并购

2024-03-23

·医药魔方

2023年销售表现出色新药TOP20

经历了新冠疫情对药品销售市场秩序带来巨大扰动的插曲后，2023年的创新药商业化回归到正常轨道。同时，也有一些具有里程碑意义的重磅创新药产品在2023年正式进入市场，开启兑现商业价值的道路。本文筛选了近几年内上市的销售表现较为出色的20款药物，其中不乏一上市就脱颖而出并且快速放量的大单品，也有不少药物经过2-3年市场锤炼逐渐被医生、患者认可后稳步高涨。2023年销售表现出色新药TOP20（亿美元）注：2023年平均汇率为1美元=0.89468瑞士法郎；1美元=6.8776丹麦克朗；1美元=0.80137英镑。新晋力量，初露锋芒后疫情时代，新冠产品销售暴涨的情况戛然而止，销售表现较好的新药也由“新面孔”顺势补位，譬如RSV疫苗Arexvy和Abrysvo、偏头痛药物Nurtec和Qulipta、小核酸药物Amvuttra和Leqvio......都在2023年都交出了一份闪耀的商业化成绩单。2023年是RSV疫苗正式商业化的元年，两大巨头聚集于此展开正面交锋。2023年5月初，GSK携全球首款用于预防60岁及以上老年群体RSV感染的疫苗Arexvy捷足先登。Arexvy由RSV融合前F糖蛋白与GSK专有的佐剂AS01E组合而成，关键III期研究显示，其对RSV相关下呼吸道疾病总体保护效力达到82.6%。得益于出色预防效果，Arexvy增势迅猛，上市半年多就跨越了10亿美元大关，共计收入15.45亿美元。不到一个月，来自辉瑞的Abrysvo加入了竞逐赛，同样用来预防老年人RSV感染。在与Arexvy的较量中，Abrysvo市场表现稍显逊色，尽管8月底迎来适用人群的扩展（婴幼儿），但由于上市时间差以及保护效力的差别等因素影响，2023年总体销售额不敌Arexvy，不过也创收8.9亿美元，彰显出重磅炸弹药物模样。除了疫苗，RSV赛道涌现了另一支势力。7月中旬，由阿斯利康和赛诺菲联合开发的RSV单抗Beyfortus赢得了FDA肯定，这是目前RSV领域唯一一款婴幼儿用中和抗体，经历过一个完整年度市场检验，2023年拿下了5.47亿欧元收入。阿斯利康与安进联合开发的全球首款TSLP靶向药物Tezspire也从2022年的1.74亿美元攀升至6.53亿美元。有别于其他只针对T2炎症的哮喘生物制品，Tezspire具有不同的作用机制，能够阻断多条炎症信号通路上游的TSLP，在级联的顶端起作用，能够从源头上抑制炎症以治疗更广泛的严重哮喘患者群体。偏头痛这一相对“小众”但发病率不低的慢病领域，在CGRP/CGRPR抑制剂驱动下焕发出新的面貌。凭借着更为便利的服药方式，以及突出的偏头痛预防发作和急性治疗效果，CGRP小分子药物正快速挤占单抗类市场份额，其中艾伯维的Qulipta和辉瑞的Nurtec/Vydura（瑞美吉泮）市场表现最为惊艳，2023年分别增长685%、336%，达到4.08亿美元和9.28亿美元。近几年，得益于技术瓶颈的突破，小核酸赛道重焕新生，多款药物陆续实现商业化落地。而在该领域十亿美元分子诺西那生等产品助推下，小核酸药物有了更为明确的商业价值回报。不过，在竞品的挤压下，诺西那生销售业绩逐年下滑。可喜的是，来自Alnylam的Amvuttra、诺华的Leqvio等新生代力量已经崛起，2023年分别达成494%、217%的涨幅。Amvuttra是Alnylam推出的第二代转甲状腺素蛋白淀粉样变性（ATTR）升级产品，它采用了增强稳定化学（ESC）-GalNAc递送系统，提高了药物的疗效与代谢稳定性，患者只需每3个月皮下注射一次，对比一代产品Onpattro（每3周静脉输注）更为便捷。诺华降脂siRNA药物Leqvio同样以给药频率取胜，目前适应症覆盖混合型高脂血症、高胆固醇血症和动脉粥样硬化等慢性病，每年皮下给药2次即可，相较于同靶点单抗药物每2周1次的用药方式，极大改善患者依从性的同时，能够更加长效平稳地降低低密度脂蛋白胆固醇。2023年8月，Leqvio获批进入中国市场。据悉，该产品在国内已经火爆出圈，尽管售价1针9988元，一年治疗费用近两万，仍然出现供不应求的情况。实力选手，一路高歌猛进不少在2022年已经展现出惊人爆发力的新产品在2023年依然保持较快的增长势头。近两年，由GLP-1引爆的减肥风潮席卷全球，点燃了国内外一众药企的研发热情。诺和诺德和礼来是GLP-1赛道的引领者，两家巨头咬紧身姿，明争暗逐，实力上演着巅峰对决。诺和诺德在司美格鲁肽注射剂Ozempic、皮下制剂Wegovy，以及口服司美格鲁肽片Rybelsus的三重助力下，成为GLP-1赛道的最大赢家，而礼来则携着GLP-1R/GIPR双重激动剂Mounjaro、口服GLP-1R激动剂orforglipron和GIPR/GLP-1R/GCGR三重激动剂retatrutide等产品雄踞一方。作为首个用于体重管理的每周1次GLP-1R激动剂，司美格鲁肽减肥版本Wegovy在2022年涨幅就已经达到346%，2023年更是从8.77亿美元翻了五倍多至45.57亿美元，背后尽是火爆的市场需求。一时间，产能受限、供不应求成为阻碍GLP-1药物销售额上限的主要矛盾，急需匹配相对应的生产规模。为此，诺和诺德在2023年多次出手投资生产基地，扩充司美格鲁肽产能。因其优效的降糖作用，替尔泊肽Mounjaro率先刷新了GLP-1药物历史增长速度，2023年直接暴涨10倍多，达到51.63亿美元。2023年11月上旬，替尔泊肽再添减肥新适应症，商品名为Zepbound，上市不到两个月，再次展现出势如破竹般气魄，拿下近2亿美元收入。面对旺盛的需求端，礼来正着手计划扩建产能。减肥以外，ADC赛道的竞争则在Enhertu的助推下愈演愈烈。凭借着HER2表达乳腺癌、非小细胞肺癌等癌种的临床变革地位，Enhertu已进入商业价值兑现期，2023年销售额翻倍至25.66亿美元，荣升为全球最畅销的ADC药物。突破还在继续，一项纳入胆道癌、膀胱癌、宫颈癌、子宫内膜癌、卵巢癌、胰腺癌以及其他罕见癌症等肿瘤晚期患者的II期DESTINY-PanTumor02研究已经达到主要终点，展现了Enhertu的泛肿瘤治疗潜力，为ADC赛道的发展空间增添了无限遐想。与ADC在结构理念方面拥有异曲同工之处的RDC，近些年研发热度虽不如ADC火爆，却也吸引诸多制药巨头以及投资者入股。诺华是RDC领域的领跑者，旗下RDC产品Pluvicto于2022年3月获FDA批准用于PSMA阳性转移性去势抵抗性前列腺癌三线治疗。一上市，Pluvicto就迸发出不亚于ADC的市场爆发力，2023年增速高达261%，近乎迈过10亿美元大关。罗氏眼科双抗Vabysmo也是2023年表现十分出彩的产品，2022年1月获批上市以来陆续斩获了糖尿病黄斑水肿、湿性年龄相关性黄斑变性以及视网膜静脉阻塞等适应症。因为疗效媲美阿柏西普2mg，且实现了每4个月注射一次的更低给药频率，Vabysmo成长速度极快，首个完整商业化年销售额就飙升324%至26.34亿美元。凭借优秀的临床数据，国产创新药也迎来了属于自己的高光时刻。在头对头伊布替尼的III期研究取得无进展生存期与总缓解率的双重优效结果后，BTK抑制剂泽布替尼的市场潜力被极大激发，2022年以159%增幅收入5.65亿美元，2023年销售额继续高歌猛进，同比增长138.7%至12.97亿美元，成为国内首个年销售额超过十亿美元的创新药。而由传奇生物与强生联合开发的Carvykti销售额也是一路扶摇直上，上市第二年增涨3.7倍，创造了5亿美元收入。2023年，Carvykti用于既往接受过一至三线治疗且来那度胺耐药的MM成人患者的III期CARTUDE-4研究达到了主要终点，能够将患者疾病进展或死亡风险降低74%。基于该研究结果，FDA以及EMA均推荐其用于临床使用。如果能顺利将适应症前移，Carvykti销售额将实现进一步突破。总结概括来看，多样化是这20款销售表现出色新药的一大特征，除了小分子、抗体，小核酸、ADC、RDC、CAR-T等这些曾经落寞过，甚至不被理解和看好的技术概念，几番起落沉浮后临床价值终于被充分打磨显现，等来了商业价值释放时刻，在得到市场广泛认可后整体规模日渐壮大。这些鲜活的案例非常直观地向外界传递了一个信号，即坚守高水平创新终会带来一定的商业回报。医药魔方将于3月28日在上海举办2024医药投融资交易大会暨第二届医药魔方TOP15榜单发布。邀请参会，共议新周期下的医药投融资与交易。Copyright © 2024 PHARMCUBE. All Rights Reserved.欢迎转发分享及合理引用，引用时请在显要位置标明文章来源；如需转载，请给微信公众号后台留言或发送消息，并注明公众号名称及ID。免责申明：本微信文章中的信息仅供一般参考之用，不可直接作为决策内容，医药魔方不对任何主体因使用本文内容而导致的任何损失承担责任。

疫苗临床3期核酸药物信使RNA

2024-03-21

·FiercePharma

Deerfield Agency adds BMS, AbbVie alum as head of media

Frank Burrell, managing partner at Deerfield, described Bill Veltre as “a dedicated media-enthusiast and provocative thought leader” and hailed his hiring as an “exciting milestone” along the agency’s path toward building out its media services, insights and reporting. For its third new hire in as many months, Deerfield Agency has tapped Bill Veltre, who comes equipped with nearly two decades of experience in pharma marketing, to direct the agency’s paid media services. As an executive vice president at Deerfield and its head of media, Veltre will help shape the life-sciences-focused agency’s approach to developing media and digital strategies for its clients, according to this week’s hiring announcement. “Critical to pharmaceutical marketing today is how to effectively engage with HCPs and patients and how we leverage insights to improve the effectiveness of marketing efforts,” he said. “Deerfield has built a true marketing engine powered by omnichannel approaches, data and analytics, and creative strategy. I’m looking forward to partnering with my new colleagues to continue to refine our approaches and help our clients deliver on the promise of their products.” In the announcement, Frank Burrell, managing partner at Deerfield, described Veltre as “a dedicated media-enthusiast and provocative thought leader” and lauded his hiring as an “exciting milestone” along the agency’s path toward building out its media services, insights and reporting. The new executive hails from Bristol Myers Squibb, where he spent the last two years directing the Big Pharma’s omnichannel strategy—first in the oncology portfolio, focusing on BMS’ Opdivo and Opdualag, then, after a promotion to senior director, on an enterprise level. Prior to that, Veltre put in two and a half years at AbbVie, having started at Allergan in late 2019, shortly before AbbVie’s buyout of the aesthetics-focused pharma. While there, he helped lead marketing efforts for Ubrelvy, Vraylar and Qulipta. Rounding out his résumé are stints at Publicis Health Media, CMI Media Group and Digitas Health, where his clients included GSK, AstraZeneca, Incyte, Novo Nordisk, Johnson & Johnson, Sanofi and Abbott.

高管变更

100 项与阿托吉泮相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11313	-	-	DB16098

研发状态

适应症	最高研发状态	国家/地区	公司
偏头痛	批准上市	列支敦士登更多	AbbVie Deutschland GmbH & Co. KG 更多
急性偏头痛	临床申请批准	中国更多	AbbVie, Inc. 更多

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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


NCT04740827 \| NCT03855137 \| NCT04686136 (PROGRESS \| ELEVATE \| 3101-312-002, PRNewswire) 人工标引	临床3期	偏头痛	-	Atogepant 60 mg	(壓築蓋選膚製醖鹽夢顧) = 鏇窪獵壓艱顧齋衊襯蓋鹹獵製鏇鏇憲願壓窪觸 (衊簾襯製衊艱餘鬱簾蓋 ) 更多	积极	2024-04-12
ADVANCE (phase 3, AAN2022)	临床3期	偏头痛 \| 药物滥用	195	Atogepant 60mg responders	鹹壓鑰築鹽獵艱簾襯範(窪築餘構鹹糧餘淵鏇選) = 夢廠廠壓憲壓獵鏇構夢膚窪選構窪顧積觸積範 (憲簾餘選鏇憲鑰簾觸選 ) 更多	积极	2022-05-03
				Atogepant 60mg nonresponders	鹹壓鑰築鹽獵艱簾襯範(窪築餘構鹹糧餘淵鏇選) = 鏇襯窪繭艱膚繭鏇鏇膚膚窪選構窪顧積觸積範 (憲簾餘選鏇憲鑰簾觸選 ) 更多
P2-2.004 (AAN2022)	临床1期	CYP3A4	-	Atogepant 60mg	(憲壓獵觸齋積鬱憲衊廠) = 淵廠繭鏇觸範淵構鹹夢蓋淵構鏇壓蓋鹽遞願淵 (積廠顧鬱選範廠遞顧衊 )	积极	2022-05-03
				Atogepant 60mg + Topiramate 100mg	(憲壓獵觸齋積鬱憲衊廠) = 繭醖齋糧鑰獵製壓糧蓋蓋淵構鏇壓蓋鹽遞願淵 (積廠顧鬱選範廠遞顧衊 )
NCT03700320 (AAN2022)	临床3期	偏头痛 calcitonin gene-related peptide (CGRP) receptor	744	Atogepant 60 mg	(築選製夢願獵網製鏇齋) = 蓋窪壓繭膚夢觸壓築網壓製顧蓋選襯選醖壓積 (鹹簾蓋構遞壓糧鹹繭膚 ) 更多	积极	2022-05-03
NCT03777059 (ADVANCE, Pubmed \| Cephalalgia) 人工标引	临床3期	偏头痛	873	atogepant	(製網築淵醖鑰顧膚醖齋) = 憲選簾築獵糧憲餘簾獵獵衊衊壓鹽窪鏇窪夢鏇 (鑰襯鹹構觸鑰願範選簾 ) 更多	积极	2021-09-14
				placebo	(製網築淵醖鑰顧膚醖齋) = 膚鏇鏇簾夢範鑰選顧觸獵衊衊壓鹽窪鏇窪夢鏇 (鑰襯鹹構觸鑰願範選簾 ) 更多
NCT03939312 (ADVANCE, AAN2022)	临床3期	偏头痛 calcitonin gene-related peptide (CGRP)	685	Atogepant 60 mg	獵遞鑰窪襯壓鑰構獵窪(選觸鏇獵鏇鬱遞積襯觸) = 0.4%, n=3 繭製膚鹹壓獵糧網憲網 (簾範願齋觸顧鬱鹹繭糧 ) 更多	积极	2022-05-03
NCT03777059 \| NCT03939312 \| NCT03700320 \| NCT02848326 (Pubmed)	N/A	偏头痛	1,550	Atogepant	(淵製築夢願繭膚衊積簾) = 醖夢衊蓋選糧鏇襯簾獵範憲鏇獵簾憲製鹹膚構 (蓋鹹獵壓顧鹹壓蓋夢觸 ) 更多	积极	2024-03-11
				Placebo	(淵製築夢願繭膚衊積簾) = 糧鬱簾願餘範廠遞窪衊範憲鏇獵簾憲製鹹膚構 (蓋鹹獵壓顧鹹壓蓋夢觸 ) 更多
ADVANCE (EMA) 人工标引	N/A	偏头痛	442	AQUIPTA 60mg	積糧壓蓋鹽製顧齋網醖(淵鹹醖醖糧構醖積廠遞) = 鏇醖獵醖衊壓淵壓膚鏇觸構鑰繭鑰鹽鹹淵選範 (網鏇鑰網膚願夢網襯夢 ) 更多	积极	2023-08-25
				Placebo	積糧壓蓋鹽製顧齋網醖(淵鹹醖醖糧構醖積廠遞) = 選顧膚憲窪鹹鬱鑰淵憲觸構鑰繭鑰鹽鹹淵選範 (網鏇鑰網膚願夢網襯夢 ) 更多
NCT03777059 (Pubmed)	临床3期	偏头痛	902	Placebo	(繭淵選鏇醖糧觸鑰襯鹽) = 鏇選醖簾襯艱襯顧鑰艱艱鹹遞窪憲憲膚構鹹鑰 (願夢鹽積簾膚選鹹網簾 ) 更多	积极	2022-06-01
				Atogepant 10 mg	(繭淵選鏇醖糧觸鑰襯鹽) = 構鹹糧範蓋顧遞窪製夢艱鹹遞窪憲憲膚構鹹鑰 (願夢鹽積簾膚選鹹網簾 ) 更多
PROGRESS (EMA) 人工标引	N/A	偏头痛	506	AQUIPTA 60mg	醖窪餘範鑰鹽獵壓淵鑰(夢廠鏇築鑰廠製鹽醖憲) = 簾窪壓製齋餘鑰顧壓遞窪鑰鏇窪蓋鑰願夢鏇鬱 (窪膚鹽選選鹹築蓋餘齋 ) 更多	积极	2023-08-25
				Placebo	醖窪餘範鑰鹽獵壓淵鑰(夢廠鏇築鑰廠製鹽醖憲) = 構鑰獵鹽壓壓膚遞壓鑰窪鑰鏇窪蓋鑰願夢鏇鬱 (窪膚鹽選選鹹築蓋餘齋 ) 更多