The goal of this project is to evaluate galcanezumab transfer into maternal breastmilk, and to evaluate infant (growth, development, constipation, colic, infections) and maternal (headache) outcomes for dyads in which the mother was treated with galcanezumab and to compare outcomes for infants who were or were not breastfed after maternal treatment.
In this prospective observational study, the study team proposes to prospectively collect serial milk samples from 30 adult women who are treated with galcanezumab for migraine. Mothers who are interested in participating will be connected with us, the main clinical site, by neurologists across the USA. Mothers must carry a diagnosis of migraine, be aged 18-45 years, and be between 14 days and 9 months postpartum, and still nursing, at the time of enrollment.
This study will fill a significant unmet need as women of childbearing potential are over-represented in the migraine population, and yet they are excluded from clinical trials of migraine treatments during pregnancy and lactation.

开始日期2023-12-01

申办/合作机构

The University of California, San Francisco

[+1]

NCT05281770 / RecruitingN/AIIT

Non-interventional Study of the Austrian Headache Society: Monoclonal CGRP Antibodies for Migraine Prevention a Nationwide Real Life Study

The present non-interventional study on migraine prevention with monoclonal CGRP antibodies adresses questions concering safety, swichting from one CGRP mab to another, efficacy on auras in the real world setting.

开始日期2022-10-01

申办/合作机构

Medical University of Vienna

[+1]

NCT05492695 / Terminated临床4期

TOGETHER STUDY: Tandem OnabotulinumtoxinA Galcanezumab Emerging Therapeutic Headache Elimination Research Study

This is a multicenter, double-blind, placebo-controlled study assessing the effectiveness of Galcanezumab as an add-on therapy for Migraine participants on a stable migraine prophylaxis regimen including Botox with or without one other migraine prophylaxis agent (BMPT), who have persistent unmet need. The study population will consist of approximately 150 participants ages 18-65 who report at least a 30% reduction in monthly migraine days from BMPT and still experience an average of ≥ 6 migraine days per month, following International Classification of Headache Disorders (ICHD-3) criteria. Subjects should be stable on at least 2, but no more than 8, consecutive injection cycles of Botox. Overall migraine day reduction will be assessed in the participants based on participant self-report (via daily electronic diaries) and medical record review.

开始日期2022-10-01

申办/合作机构

Diamond Headache Clinic, Ltd.

100 项与加卡奈珠单抗相关的临床结果

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100 项与加卡奈珠单抗相关的专利（医药）

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369

项与加卡奈珠单抗相关的文献（医药）

2024-02-01·Headache

Effect of galcanezumab in women with episodic migraine meeting criteria for menstrually related migraine: A post hoc analysis of EVOLVE‐1 and EVOLVE‐2

Article

作者: Detke, Holland C. ; Pavlovic, Jelena M. ; Polavieja, Pepa ; Fernandes, Maria S. ; Okonkwo, Rose ; MacGregor, E. Anne

Abstract:

Background:

We evaluated galcanezumab for migraine prevention in patients who met International Classification of Headache Disorders, 3rd edition criteria for menstrually related migraine (MRM).

Methods:

Patients were identified post hoc from three double‐blind, randomized, phase 3 clinical trials in patients with episodic migraine. Patients completed a 1‐month prospective baseline period and up to 6 months (EVOLVE‐1 and ‐2, studies pooled) of double‐blind treatment with galcanezumab (120 mg/month) or placebo. Menses and headache information were recorded by electronic daily diary. Patients with a migraine attack starting during the 5‐day perimenstrual interval (first day of bleeding ± 2 days) for ≥2 of their first three diary‐recorded menstrual cycles were categorized as having MRM. The primary efficacy measure was mean change in monthly migraine headache days from baseline, averaged over Months 4 through 6. Response rates, change in monthly perimenstrual migraine headache days, monthly non‐perimenstrual migraine headache days, and quality of life were also assessed.

Results:

Post hoc MRM analysis criteria were met by 462/1133 women (41%). Mean (standard deviation) baseline monthly migraine headache days were 9.7 (±3.1; n = 146) for galcanezumab‐treated patients and 9.6 (±2.8; n = 316) for placebo‐treated patients. The mean change (standard error [SE]) in migraine headache days over Months 4 through 6 was −5.1 days (±0.39) for galcanezumab versus −3.2 (±0.35) for placebo (p < 0.001). The mean change (SE) in perimenstrual migraine headache days over Months 4 through 6 was −0.75 days (±0.08) for galcanezumab versus −0.49 (±0.07) for placebo (p = 0.004). For migraine headache days outside the perimenstrual period, the mean change in migraine headache days was −4.6 (±0.38) for galcanezumab and −2.8 (±0.33) for placebo (p < 0.001). Improvements in response rates and the Migraine‐Specific Quality of Life Questionnaire were also observed over Months 4 through 6.

Conclusion:

Galcanezumab was effective for migraine prevention in women with MRM.

2024-02-01·Neurology and therapy

Comparing the Efficacy and Safety of Galcanezumab Versus Rimegepant for Prevention of Episodic Migraine: Results from a Randomized, Controlled Clinical Trial

Article

作者: Pandey, Hitendra ; Goadsby, Peter J ; Schwedt, Todd J ; Varnado, Oralee J ; Pearlman, Eric M ; Vargas, Bert B ; Richardson, Diane R ; Martinez, James M ; Cobas Meyer, Michael ; Myers Oakes, Tina M

INTRODUCTION:

There have been no prior trials directly comparing the efficacy of different calcitonin gene-related peptide (CGRP) antagonists for migraine prevention. Reported are the results from the first head-to-head study of two CGRP antagonists, galcanezumab (monoclonal antibody) versus rimegepant (gepant), for the prevention of episodic migraine.

METHODS:

In this 3-month, double-blind, double-dummy study, participants were randomized (1:1) to subcutaneous (SC) galcanezumab 120 mg per month (after a 240 mg loading dose) and a placebo oral disintegrating tablet (ODT) every other day (q.o.d.) or to rimegepant 75 mg ODT q.o.d. and a monthly SC placebo. The primary endpoint was the proportion of participants with a ≥ 50% reduction in migraine headache days per month from baseline across the 3-month double-blind treatment period. Key secondary endpoints were overall mean change from baseline in: migraine headache days per month across 3 months and at month 3, 2, and 1; migraine headache days per month with acute migraine medication use; Migraine-Specific Quality of Life Questionnaire Role Function-Restrictive domain score at month 3; and a ≥ 75% and 100% reduction from baseline in migraine headache days per month across 3 months.

RESULTS:

Of 580 randomized participants (galcanezumab: 287, rimegepant: 293; mean age: 42 years), 83% were female and 81% Caucasian. Galcanezumab was not superior to rimegepant in achieving a ≥ 50% reduction from baseline in migraine headache days per month (62% versus 61% respectively; P = 0.70). Given the pre-specified multiple testing procedure, key secondary endpoints cannot be considered statistically significant. Overall, treatment-emergent adverse events were reported by 21% of participants, with no significant differences between study intervention groups.

CONCLUSIONS:

Galcanezumab was not superior to rimegepant for the primary endpoint; however, both interventions demonstrated efficacy as preventive treatments in participants with episodic migraine. The efficacy and safety profiles observed in galcanezumab-treated participants were consistent with previous studies.

TRIAL REGISTRATION:

ClinTrials.gov-NCT05127486 (I5Q-MC-CGBD).

2024-01-01·Handbook of clinical neurology

CGRP monoclonal antibodies and CGRP receptor antagonists (Gepants) in migraine prevention

Review

作者: Alpuente, Alicia ; Pozo-Rosich, Patricia ; Caronna, Edoardo ; Torres-Ferrus, Marta

Migraine is a prevalent and disabling neurological disease. Its preventive treatment for decades has been rather limited due to the absence of disease-specific therapies with limited efficacy and tolerability. The advances made in migraine research have led to the discovery of the calcitonin gene-related peptide (CGRP) and its role in migraine pathophysiology. CGRP is a neuropeptide that acts as potent vasodilator and is involved in pain processing. Increased levels of plasma CGRP have been observed during migraine attacks as well as interictally when comparing patients with migraine and healthy controls. In the last years, two classes of drugs antagonizing CGRP have therefore been developed as the first migraine-specific preventive treatments: anti-CGRP monoclonal antibodies (mAbs) and gepants. Four mAbs have been approved: erenumab, galcanezumab, fremanezumab, and eptinezumab. Gepants are small molecules that antagonize the CGRP receptor; currently only rimegepant and atogepant have been approved for migraine prevention. These new drugs have demonstrated efficacy and safety in clinical trials for both episodic and chronic migraine, and results from their real-world experience are being increasingly reported in literature. In this review, we provide an overview of anti-CGRP drugs and their placement in migraine prevention.

117

项与加卡奈珠单抗相关的新闻（医药）

2024-09-10

·CPHI制药在线

金角银边草肚皮，礼来下一招落子何处？

关注并星标CPHI制药在线在GLP-1多肽tirzepatide包装的Mounjaro和Zepbound加持之下，礼来不仅成为制药行业2024年第二季度表现最佳的制药巨头，还有可能继续抟扶摇而上，在tirzepatide产品带来的巨大利润之下持续高歌猛进。 1. 譬如北辰，二季度礼来表现亮眼在前25名制药业巨头中，礼来第二季度销售额的同比增长以36%的数据高居榜首。2024年第二季度，整个制药行业的销售额持续飙升。在排名前 25 位的制药商中，有 9 家公司的销售额同比增长了两位数，另外 9 家公司在第二季度的销售额增长了 6% 至 9% 之间（图1）。值得注意的是，自 2023 年第二季度以来，礼来的收入每季度同比增长至少 28%。图1. 25位制药业巨头2024年第二季度销售额同比变化图。（图片来源：Fierce Pharma）受到第二季度销售额业绩的背书，前 25 家制药商中有超过一半对其年度销售预测做出了积极调整。礼来调整幅度最大，将预期上调了 30 亿美元，这是第一季度销售额业绩出炉后礼来上调全年销售额20亿美元之后的又一次上调，显示了礼来对公司全年表现的高度自信。市值变化方面，礼来又排在了制药行业第一，他们第二季度的市值增长了16%。排在礼来之后的是阿斯利康（15%），Vertex（12%），莫德纳（11%）和诺和诺德（11%）。礼来和诺德诺德保持高速增长的势头可能会持续一段时间。据 GlobalData发布的最新报告显示，到 2030 年，这两家公司预计将占据 GLP-1 糖尿病和肥胖症市场的 94%，到 2030 年，这个市场规模将达到 1420 亿美元，而去年 GLP-1 市场规模“仅为”370 亿美元。礼来的生产能力在第二季度也达到了新高，糖尿病药物 Mounjaro 的销售额达到 31 亿美元，超过了 24 亿美元的普遍预期。与此同时，其减肥药 Zepbound 的销售额达到 12 亿美元，超过了分析师预测的 8.19 亿美元。值得注意的是，尽管日进斗金，但诺和诺德和礼来还远未满足市场对减肥药不断增长的需求，而且这些药物上市以来一直处于短缺状态，这为包括罗氏、辉瑞和安进等巨头以及 Zealand Pharma 和 Viking Therapeutics 等新贵在内的竞争对手提供了空间。 2. 减肥药开发，止于至善虽然礼来已经凭借 Zepbound 获得了约 40% 的减肥市场份额，但同诺和诺德一样，礼来并没有固步自封，而是依然深耕GLP-1药物的潜在市场。礼来的管线中拥有两款III期减肥药资产，一款是口服GLP-1药物orfoglipron，另一款是令行业翘首期待的所谓3G多肽减肥药retatrutide（GLP-1, GIP, Glucagon三重受体共激动剂，故而得名）。Orfoglipron的III期数据预计2025年公布，而retatrutide的III期结果可能在2026年揭晓。除此之外，礼来管线中还有四款处于I, II期的减肥资产。除了开发新型减肥药之外，礼来还在积极扩大其GLP-1产品的标签范围。礼来最新的结果显示，tirzepatide在预防II型糖尿病方面表现出了不错的潜质，还有可能在其他适应症领域，包括MASH (代谢相关性脂肪型肝炎)、帕金森病、心血管疾病和肾脏疾病等方面取得成功。礼来正在积极寻求在 Zepbound 的标签中添加治疗睡眠呼吸暂停的应用，如果获得批准，它将成为首个针对该疾病根本原因的药物治疗。 3. 抗体开发，于我心有戚戚焉在GLP-1多肽药物取得空前成功的情况下，礼来将未来的目标瞄准了抗体药物。他们在 8 月 22 日与瑞典Oblique Therapeutics AB 签署了一项研究合作协议，将应用Oblique 的 AbiProt 技术来生成针对“高价值”靶点的抗体。 AbiProt 使用蛋白酶作为分子探针来扫描整个完整蛋白质，识别可访问抗体结合位点。这个技术平台可以识别新的治疗性抗体，不仅可以以高特异性和亲和力与靶蛋白结合，而且可能针对特定的药理功能进行编辑。据猜测，礼来可能将这项技术应用于疼痛管理的药物开发领域。2021 年Science Advances杂志上的一篇论文介绍了使用AbiProt技术平台生成针对 TRPV1 通道的抗体。TRPV1（transient receptor potential cation channel subfamily V member 1）是一种离子通道蛋白，在疼痛感知和温度调节中起关键作用。礼来一直在研究疼痛管理，而Oblique 的平台也适用于礼来感兴趣的其他领域，包括肿瘤学。交易双方目前均未披露研究该项研究的目标受体及其应用。无论礼来抗体药物开发的领域是否瞄准疼痛管理，但礼来积极拓展疼痛管理疗法开发的目标，在他们近期的一项交易中再次明确地得到表现。礼来和 Organon BioSciences N.V. 之前已就偏头痛预防的单抗药物 Emgality (galcanezumab) 在欧洲的商业化展开合作达成一致。8 月 20 日，合作双方同意扩大协议范围，将Emgality的商业化权利扩展到另外11个国家与地区。Organon将向礼来支付2250万美元的预付款。除了欧盟，Organon 现在还将在加拿大、哥伦比亚、以色列、韩国、科威特、墨西哥、卡塔尔、沙特阿拉伯、中国台湾、土耳其和阿拉伯联合酋长国销售 Emgality。此前的12 月 18 日，Organon已经向礼来公司预付了 5000 万美元，用于Emgality在欧洲的权利。 4. 新实验室开张，基因疗法喷薄欲出 8月13日，礼来在波士顿海港区揭幕了一座占地超过3万平米的实验室，将容纳礼来500 名科学家，专注于利用人类遗传学的基本机制来研发药物。尽管GLP-1药物为礼来带来了源源不断的财富，但在瞬息万变的医药领域，朝生暮死也不是极其罕见的事情，礼来似乎正在秉持这一种居安思危的理念谋划公司未来的前景。Tirzepatide虽然创造出了巨大的成功， 2024年第二季度，Mounjaro和Zepbound为礼来创造出了超过三分之一的销售额，但过于倚仗某一类产品对于礼来这样体量的制药公司来说未必是好事。后继乏力的现象在制药界并不罕见。例如辉瑞在创造了Lipitor（高胆固醇药物）奇迹之后陷入了长达十年的研发瓶颈期。礼来目前的居安思危，就是借鉴制药行业的前车之鉴而避免重蹈覆辙。而保持持续性的创新能力的最重要的两个手段，无外乎外部收购和内部研发。基因疗法将是礼来未来发展的重要方向。礼来在波士顿新开张的实验室将专注于基于DNA和RNA的药物，包括利用病毒载体将遗传物质带入细胞的基因疗法，也包括 RNA 沉默疗法。听力损失是礼来可能具有优势的一种疗法开发。礼来在今年 1 月表示，第一位接受基因治疗遗传性听力损失的患者能够再次听到声音，预计此类治疗将在未来几年帮助数千人。慢性疼痛的基因疗法也是礼来考虑的先进疗法开发方向。礼来正在开发的lepodisiran是一种siRNA的RNA 沉默疗法，可以降低血液中的脂蛋白 (a)，又称 lp(a)。Lp(a)会增加心血管风险。Lp(a) 水平不受现有的降脂疗法或生活方式干预的影响。升高的lp(a) 实际上是心血管风险中一个无法治疗的因素。目前还没有 FDA 批准的降低 Lp(a) 水平的疗法，但现在有四种有希望的试验疗法正在临床试验中，lepodisiran就是其中之一。Lepodisiran目前处于临床II期研究，预计今年十月可能读数。礼来计划在今年开展该项目的III期研究。波士顿新实验室的启用，标志着礼来对于基因疗法的高度重视。礼来表示，基因药物已占其正在开发的疗法的三分之一左右。它们的开发时间也比传统药物要短。除此之外，新实验室还将肩负礼来的优先疾病领域（如糖尿病、肥胖症和心血管疾病）的新药物靶点开发。 5.总结在取得tirzepatide这一超级成功药物的辉煌成绩后，礼来公司正展望未来，以确保持续的增长和市场领导地位。公司深知，成功不仅依赖于当前的辉煌，还需要前瞻性的战略规划和持续的创新来保持竞争力。市值已逼近9000亿美元的礼来不仅是制药行业的翘楚，在全球上市公司中也稳居第十的位置。何时成为第一家跻身“万亿俱乐部”的制药公司，已成为业界热议的话题。高处不胜寒，面对这样的高位，礼来正处于行业风口浪尖，需在多个方面继续推动自身的增长与发展。寻找新的增长点对于大型制药公司至关重要。这不仅是为了应对当前市场的挑战，也是为了在未来实现持续的业务发展和市场扩展。通过不断创新和探索新领域，公司能够确保其在激烈的竞争环境中保持领先地位，并持续推动行业的进步和发展。礼来正采取积极的措施，未雨绸缪，准备迎接未来的挑战和机遇。在制药行业中，单一产品的成功并不能保证长期的市场优势。礼来正在广泛探索新的研发领域和创新技术，构建一个多元化且强大的产品管线。此外，礼来还致力于拓展和深化其在现有市场的布局，同时也在积极探索新的市场和应用领域。公司计划通过持续的产品创新和市场拓展，进一步巩固其在糖尿病、肥胖症以及其他关键疾病领域的影响力。在研发方面的持续投入也是未来成功的重要保障。礼来正在致力于推进其研发管线中的多个关键项目，并通过战略性的资源配置和技术引进，推动新药的开发和上市。公司对未来的研发方向充满信心，期望通过创新的药物和治疗方案，为患者带来新的希望，同时为公司自身带来新的增长动力。 Ref. Dunleavy, K. With 36% increase, Eli Lilly leads industrywide sales boom in Q2. Fierce Pharma. 22. 08. 2024. Hart, R. Eli Lilly Surges On Strong Earnings As Mounjaro And Zepbound Sales Soar. Forbes. 08. 08. 2024. Taylor, N. P. Eli Lilly seeks new angle on high-value target, tapping Oblique for antibody discovery push. Fierce Biotech. 22. 08. 2024. Haas, J. Deal Watch: Lilly Turns To Oblique For Antibody Discovery. Scrip. 23. 08. 2024. Manalac, T. Lilly Opens $700M R&D Center in Boston for Genetic Medicines. BioSpace. 14. 08. 2024. END 【智药研习社直播预告】来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

临床3期

2024-09-05

·Pharmaceutical Technology

Lilly and EVA Pharma to expand baricitinib access in Africa

The agreement is part of Lilly’s 30×30 strategy. Credit: rafa press/Shutterstock. Eli Lilly and EVA Pharma have formed a partnership to increase the availability of baricitinib in 49 low to middle-income African countries by 2030. Baricitinib is a Janus kinase (JAK) inhibitor indicated for Covid-19, adults with severe alopecia areata and those with moderately to severely active rheumatoid arthritis who have not responded adequately to tumour necrosis factor blockers. The initiative is part of Lilly’s 30×30 strategy, which seeks to enhance health care for 30 million people in resource-limited areas annually by 2030. Incyte discovered baricitinib, which is licensed to Lilly and marketed under the brand name Olumiant. The collaboration will utilise EVA Pharma’s high-containment facility, which is poised to begin distributing locally manufactured baricitinib by 2026 to the agreed territories. See Also: UK NHS launches vaccine programme for RSV Novavax wins FDA emergency approval for updated Covid-19 vaccine The agreement will leverage the pan-African network of EVA Pharma and its local production capabilities, which adhere to international standards. This enables Lilly to extend the medicine’s reach to regions where access to such treatments is often limited. Lilly International executive vice-president and president Ilya Yuffa stated: “Our commitment to expanding access to affordable and innovative medicines for people living in low to middle-income countries continues. “Following our collaboration with EVA Pharma on insulin manufacturing, we are now establishing the first of its kind voluntary licensing agreement for Lilly, where the company will provide certain baricitinib manufacturing know-how to enable EVA Pharma to manufacture and supply baricitinib to people in 49 countries across Africa.” EVA Pharma has been collaborating with Lilly since 2021 to ensure a consistent supply of essential medicines in a number of African nations. The two companies are working together to enhance the affordability and accessibility of insulin in 56 primarily low to middle-income countries, as disclosed in 2022. EVA Pharma CEO Riad Armanious stated: “We are proud to localise the entire value chain of this critical medication on the continent, from producing high-potency baricitinib active pharmaceutical ingredients to tackling complex manufacturing challenges.” The latest development comes after Lilly expanded a commercial agreement , under which Organon will be the sole distributor and promoter of the migraine medication Emgality (galcanezumab) in 11 new markets.

疫苗引进/卖出上市批准

2024-08-21

·空之客

【医苑观畴】2024年二季度海外药企进展更新：辉瑞PFE

1 整体表现曾经的宇宙第一大厂辉瑞，在新冠口服药和疫苗的潮水迅速退去的过程中，仿佛又回到了业绩增长点全线哑火的尴尬境地，于是市值从22年最风光时短暂达到过的$300b、近期又回到了$150b左右，在大药企的市值排名一下落到第9名（顺便吐个槽，自从疫情结束后，PFE看点急剧衰竭的程度从季报篇幅的缩水就可见一斑，这家顶级MNC的季报如果不算封面封底脚注居然只有10页纸……）扣除新冠产品以外的收入同比增长14%，但其实其中也有一大半的增量又是来源于合并SGEN那些ADC产品，所以实际上可比的内生增长依然非常微不足道，而且净利润也在下降。 2 已上市产品肿瘤板块的业绩只能说是小打小闹，最粗的大腿Palbociclib早已日薄西山，Enzalutamide看起来在联用PARP抑制剂获批之后确实对销售额颇有贡献、LTM累计已达到$1.5b，BRAF+MEK组合这个季度也有所起色、单季$150m，不过$43b重金买来的SGEN单季度只贡献了区区$827m、爬坡也算不上明显、不知道距离2030年贡献超过$10b这个目标还有多远。免疫炎症板块更是惨不忍睹，老迈不堪的Tofacitinib和Etanercept正在一路下滑，而新一代JAK抑制剂Abrocitinib上市两年多LTM累计才$163m，与单季度都已经$1.4b的Upadacitinib一比简直高下立判。传染病板块里，除去新冠两兄弟的一地鸡毛，也就靠LTM累计$6.5b的肺炎疫苗Prevnar独撑危局了，新上市的RSV疫苗Abrysvo首个年度打破$1b大关也算给未来留下看点。其他产品倒是看点颇多：Apixaban还算是老骥伏枥，加上BMS部分LTM累计已接近$20b大关；TTR稳定剂Tafamidis划出一条完美的成长曲线，LTM累计已高达$4.3b，尽管面对后续ALNY和BBIO的潜在冲击，至少已经证明ATTR-CM/PN的确是有巨大潜力的适应症（参见【药海听涛】太阳神终于降临：Alnylam公布HELIOS-B三期结果）；偏头痛药物Rimegepant也改出了此前几个季度走平的状态，LTM累计突破$1.0b，至少作为同适应症药物已经超越了LLY的Galcanezumab、ABBV的Atogepant和Ubrogepant、NVS的Erenumab，成为偏头痛和CGRP中市场份额的领跑者。 3 在研管线这个季度PFE最吸睛的消息就是小分子GLP-1的“借尸还魂”，在此前终止了Danuglipron每日两次剂型的开发后，每日一次控释剂型的优化完成并准备启动桥接试验。基因治疗好像久远得像上古时代的产物，PFE曾经在这里砸下的重金也总算听到点儿回响，治疗A型血友病的AAV项目SB-525读出了三期临床的topline数据，从输注后第12周到至少15个月的随访期间，单次3e13 vg/kg SB-525与八因子替代预防疗法相比，平均总年化出血率（ABR）为1.24 vs 4.73（p=0.0040）；然而另一个治疗DMD的AAV项目却遭遇三期临床失败。除此以外，值得关注的进展还包括：Adcetris公布了联用Lenalidomide和Rituximab治疗DLBCL的三期临床数据并提交sBLA，长效生长激素Somatrogon向欧洲药监部门提交上市申请，RSV疫苗Abrysvo公布了免疫低下成年人群的三期临床数据、并获批Act-O-Vial剂型，BCMA/CD3双抗Elranatamab公布二期临床中1L MM亚组的OS数据，。说得不客气点，PFE就像一具被新冠业务吸干了精气的僵尸，庞大的身躯虽然仍有动作，却表现出令人费解的茫然混沌，早已失去了曾经作为宇宙第一大药企的方向感和驱动力。从他其实早早发了季报，我直到现在才愿意细看一眼（然而并没看到什么值得期待的内容），就知道期望值有多低……

疫苗临床3期基因疗法财报引进/卖出

100 项与加卡奈珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	加卡奈珠单抗	N02CD02	DB14042

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
丛集性头痛	美国	Eli Lilly & Co.	2019-06-04
偏头痛	美国	Eli Lilly & Co.	2018-09-27

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
膝关节炎	临床2期	美国	Eli Lilly & Co.	2014-07-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05284019 (EVEC, CTgov)	临床4期	偏头痛	32	Onabotulinumtoxin-A (Onabotulinumtoxin-A)	糧糧餘醖鹽顧築蓋選餘(餘網鹹簾壓淵壓積網積) = 淵鏇齋廠壓構範繭繭廠鬱簾糧艱鑰鬱廠製遞觸 (構餘網鏇鬱窪獵襯製顧, 襯壓淵醖憲齋蓋願餘齋 ~ 鏇遞夢構選範範壓選壓) 更多	-	2024-05-29
				Eptinezumab (Eptinezumab)	糧糧餘醖鹽顧築蓋選餘(餘網鹹簾壓淵壓積網積) = 構襯鬱獵鑰衊獵製鏇淵鬱簾糧艱鑰鬱廠製遞觸 (構餘網鏇鬱窪獵襯製顧, 憲淵憲鏇鹽窪廠廠繭顧 ~ 膚鏇觸鏇觸製齋窪鹽鑰) 更多
Pubmed	N/A	偏头痛	-	Galcanezumab 120 mg	艱廠製鹹齋膚鑰網夢夢(築選齋鑰蓋繭艱積願夢) = 鑰鏇獵廠鏇餘獵構憲遞獵鑰醖願範艱獵網鏇衊 (蓋淵齋簾壓積範窪鹹蓋, 4.64)	-	2024-04-06
				Galcanezumab 240 mg	艱廠製鹹齋膚鑰網夢夢(築選齋鑰蓋繭艱積願夢) = 選鹽積壓顧範鬱簾網積獵鑰醖願範艱獵網鏇衊 (蓋淵齋簾壓積範窪鹹蓋, 3.85)
P10-12.006 (AAN2023)	临床3期	偏头痛	-	Galcanezumab 120mg with a 240mg loading dose	艱醖醖廠簾繭齋醖範鏇(範選鬱鹹製觸窪壓積構) = 0.6% 簾繭願觸艱遞壓願蓋窪 (積顧鹹窪鬱網鑰顧顧鹽 ) 更多	积极	2023-04-25
				Placebo
AAN2023	N/A	偏头痛	20	Fremanezumab	遞齋淵鑰艱衊艱蓋膚築(鑰製願積顧簾鏇範廠繭) = 鹽選觸網積蓋淵觸鏇蓋鏇艱獵鹽鏇鬱鹹鑰選糧 (窪網繭憲醖窪糧簾鏇繭 ) 更多	积极	2023-04-25
NCT03963232 (PERSIST, Pubmed) 人工标引	临床3期	偏头痛	520	Galcanezumab-gnlm	積膚構築襯築夢鏇願遞(鹹鏇鑰網顧艱築餘簾遞) = 蓋遞衊衊壓鏇糧廠艱積獵顧衊遞鏇蓋顧製鑰壓 (夢積鏇蓋鑰鹽簾選齋鑰 ) 更多	积极	2022-07-28
				Placebo	積膚構築襯築夢鏇願遞(鹹鏇鑰網顧艱築餘簾遞) = 廠齋繭鑰積淵積艱壓醖獵顧衊遞鏇蓋顧製鑰壓 (夢積鏇蓋鑰鹽簾選齋鑰 ) 更多
Pubmed 人工标引	N/A	疼痛 \| 偏头痛	43	Galcanezumab	獵壓鑰衊鏇範齋網醖鹹(襯廠餘顧醖範遞衊獵夢) = 蓋積築鬱膚製糧艱鑰願鹽顧簾廠繭蓋範鹹鹽襯 (窪網糧艱鏇夢鹹網壓齋 ) 更多	积极	2022-06-13
NCT02797951 (Pubmed) 人工标引	临床3期	丛集性头痛	164	Galcanezumab-gnlm	遞壓遞餘範選襯醖糧願(襯鬱鹹鑰夢鬱構夢鬱積) = 衊構築網觸齋糧顧鹹壓遞糧鏇選範鏇壓築淵積 (鹹醖齋遞積鏇觸選醖遞 ) 更多	积极	2022-05-27
NCT02614261 (REGAIN, Pubmed \| Curr Med Res Opin)	临床3期	偏头痛	1,022	Galcanezumab loading dose (240mg)	積築鬱顧餘願衊壓淵憲(鑰鏇蓋憲製膚衊醖鹹餘) = Incidence of discontinuation from the OLE due to adverse events was 5%. 製觸齋積蓋遞範範鬱遞 (襯襯鑰廠構願醖顧膚願 )	积极	2022-04-08
				Galcanezumab 120mg/month
NCT04294147 (CTgov)	临床4期	偏头痛	65	Erenumab (140 mg Erenumab SC)	憲鹽糧築憲鏇襯窪顧糧(願願糧窪夢簾蓋範鏇蓋) = 艱遞選糧鏇鬱鑰範構窪願醖壓衊製糧築齋窪構 (築鑰獵顧醖鹽憲積獵襯, 簾遞憲餘製鑰廠憲餘鹽 ~ 蓋淵獵製願壓鏇築構選) 更多	-	2022-03-22
				Galcanezumab (240 mg Galcanezumab SC)	憲鹽糧築憲鏇襯窪顧糧(願願糧窪夢簾蓋範鏇蓋) = 夢選網積鹹憲襯簾膚醖願醖壓衊製糧築齋窪構 (築鑰獵顧醖鹽憲積獵襯, 鏇獵淵遞窪繭餘艱憲鬱 ~ 廠範鏇製廠鬱淵齋遞範) 更多