A Multicenter, Open-label, Single-arm, Multiple-dose Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Ceftobiprole Medocaril in Term and Pre-term Neonates and Infants up to 3 Months of Age With Late-onset Sepsis

This study will evaluate the safety, pharmacokinetics and efficacy of ceftobiprole in term and pre-term newborn babies and infants up to 3 months of age with late-onset sepsis (LOS). Ceftobiprole is an antibiotic which belongs to a group of medicines called 'cephalosporin antibiotics'. It is approved for its use to treat adults and children with pneumonia in many European and non-European countries.

开始日期2023-08-06

申办/合作机构

Basilea Pharmaceutica AG

EUCTR2022-001837-35-LT / Unknown status临床3期

A multicenter, open-label, single-arm, multiple-dose study to evaluate the safety,pharmacokinetics, and efficacy of ceftobiprole medocaril in term and pre-termneonates and infants up to 3 months of age with late-onset sepsis

开始日期2023-02-27

申办/合作机构

Basilea Pharmaceutica International Ltd.

NCT04171674 / Unknown statusN/AIIT

A Study on Plasma and Pulmonary Pharmacokinetics of High-dose Ceftobiprole Given by Continuous Infusion in Mechanically-ventilated Adult Patients With Severe Community-acquired Pneumonia

The main aim of the study is to describe plasma pharmacokinetics (PK) and pulmonary diffusion of high-dose ceftobiprole (500 mg loading dose followed by 2.5 g under continuous infusion for 24h) for mechanically-ventilated adult patients with severe community-acquired pneumonia, using population PK modelling.
The secondary aims are :
A- To determine whether the pharmacokinetic / pharmacodynamic (PK/PD) targets can be achieved in the plasma and epithelial lining fluid with the recommended doses of ceftobiprole.
B- To define the optimal dose regimen for ceftobiprole in this population.
C- To evaluate clinical recovery (at Day 3 and Day 8) and microbiological recovery (at Day 3).
D- To evaluate the clinical evolution.
E- To evaluate the clinical and biological tolerance.

开始日期2021-09-01

申办/合作机构

Centre Hospitalier Universitaire de Bordeaux

100 项与头孢比罗酯钠相关的临床结果

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100 项与头孢比罗酯钠相关的转化医学

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100 项与头孢比罗酯钠相关的专利（医药）

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项与头孢比罗酯钠相关的文献（医药）

2024-04-01·Seminars in respiratory and critical care medicine

Antibiotic Strategies for Severe Community-Acquired Pneumonia

Review

作者: Fantin, Alberto ; Magnasco, Laura ; Giacobbe, Daniele R ; Castaldo, Nadia ; Vena, Antonio ; Bassetti, Matteo

Abstract:

Despite advancements in health systems and intensive care unit (ICU) care, along with the introduction of novel antibiotics and microbiologic techniques, mortality rates in severe community-acquired pneumonia (sCAP) patients have not shown significant improvement. Delayed admission to the ICU is a major risk factor for higher mortality. Apart from choosing the appropriate site of care, prompt and appropriate antibiotic therapy significantly affects the prognosis of sCAP. Treatment regimens involving ceftaroline or ceftobiprole are currently considered the best options for managing patients with sCAP. Additionally, several other molecules, such as delafloxacin, lefamulin, and omadacycline, hold promise as therapeutic strategies for sCAP. This review aims to provide a comprehensive summary of the key challenges in managing adults with severe CAP, focusing on essential aspects related to antibiotic treatment and investigating potential strategies to enhance clinical outcomes in sCAP patients.

2024-02-01·Infectious diseases now

Real-life use of ceftobiprole for severe infections in a French intensive care unit

Article

作者: Micaelo, Maité ; Bellut, Hugo ; Arrayago, Marine ; Bruneel, Fabrice ; Bedos, Jean-Pierre ; Roujansky, Ariane ; Amara, Marlène

Ceftobiprole (CBP) is an anti-methicillin-resistant Staphylococcus aureus (MRSA) cephalosporin with a wide spectrum of activity. We aimed to describe our experience of real-life use of CBP for the treatment of severe infections of critically ill patients with multiple infected sites and related trough CBP concentrations. We performed a retrospective, observational, monocentric study in our intensive care unit (ICU) that included all patients treated with CBP for documented infections between January 2016 and December 2021. We collected demographic, clinical, and microbiological data. When available, we report the CBP trough concentrations. The primary endpoint was clinical cure at the end of treatment. The secondary endpoints were in-hospital mortality and documentation of the carriage of multidrug-resistant (MDR) bacteria not present before CBP treatment. Between January 2016 and December 2021, 47 patients were treated in the ICU with CBP. The main indication for treatment was pneumonia (51%) and most patients presented with associated bacteremia (72%). All infections were polymicrobial. A clinical cure was achieved for nearly 80% of the patients. Only five patients presented new carriage of MDR bacteria. In-hospital mortality was 32%. Out of 21 strains of Enterobacterales for which the MIC was available, 33% were considered to be resistant to CBP according to the EUCAST 2023 clinical breakpoint. Trough CBP concentrations were reported for 16 patients. In our real-life experience, treatment of ICU patients with CBP for polymicrobial severe infections resulted in most cases in a clinical cure. Monitoring of trough concentrations is critical, especially in cases of high MIC.

2024-01-02·Expert opinion on drug safety

Safety and effectiveness of fifth generation cephalosporins for the treatment of methicillin-resistant staphylococcus aureus bloodstream infections: a narrative review exploring past, present, and future

Review

作者: Viale, Pierluigi ; Bussini, Linda ; Bavaro, Davide Fiore ; Diella, Lucia ; Cento, Valeria ; Gatti, Milo ; Saracino, Annalisa ; Bartoletti, Michele ; Belati, Alessandra ; Pea, Federico

INTRODUCTION:

Methicillin-resistant Staphylococcus aureus (MRSA) bloodstream infection (BSI) is a major issue in healthcare, since it is often associated with endocarditis or deep site foci. Relevant morbidity and mortality associated with MRSA-BSIs forced the development of new antibiotic strategies; in particular, this review will focus the attention on fifth-generation cephalosporins (ceftaroline/ceftobiprole), that are the only ß-lactams active against MRSA.

AREAS COVERED:

The review discusses the available randomized controlled trials and real-world observational studies conducted on safety and effectiveness of ceftaroline/ceftobiprole for the treatment of MRSA-BSIs. Finally, a proposal of MRSA-BSI treatment flowchart, based on fifth-generation cephalosporins, is described.

EXPERT OPINION:

The use of anti-MRSA cephalosporins is an acceptable choice either in monotherapy or combination therapy for the treatment of MRSA-BSIs due to their relevant effectiveness and safety. Particularly, their use may be advisable in combination therapy in case of severe infections (including endocarditis or persistent bacteriemia) or in monotherapy in subjects at higher risk of drugs-induced toxicity with older regimens. On the contrary, caution should be taken in case of suspected/ascertained central nervous system infections due to inconsistent data regarding penetration of these drugs in cerebrospinal fluid and brain tissues.

项与头孢比罗酯钠相关的新闻（医药）

2024-06-20

·BioSpace

Basilea partners oncology drug candidate lisavanbulin with Glioblastoma Foundation

Allschwil, Switzerland, June 20, 2024 Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that it has entered into an asset purchase agreement with the Glioblastoma Foundation Inc., for Basilea’s oncology drug candidate lisavanbulin (BAL101553), which has been developed as a potential therapy for glioblastoma, the most common type of primary brain cancer.1 Dr. Marc Engelhardt, Chief Medical Officer of Basilea, said: “Glioblastoma is one of the most lethal types of brain cancer and available therapeutic options are very limited. Partnering lisavanbulin with the Glioblastoma Foundation is important to us, as it enables patients to continue having access to this promising anticancer drug candidate, now that Basilea has changed its strategic focus to anti-infectives.” Dr. Gita Kwatra, Chief Executive Officer of the Glioblastoma Foundation, said: “We are delighted to partner with Basilea and take over the development of lisavanbulin for glioblastoma patients. Lisavanbulin has shown excellent activity against glioblastoma in PDX preclinical models as well as efficacy in phase 1 and 2 studies. We strongly believe that lisavanbulin will be effective in a subset of glioblastoma patients and we are looking forward to initiating clinical trials of lisavanbulin in the US.” Under the terms of the agreement, Basilea sells and transfers all rights to lisavanbulin to the Glioblastoma Foundation for an undisclosed initial purchase price. In addition, Basilea will participate in future proceeds from any potential commercial partnerships at a fixed double-digit percentage. The Glioblastoma Foundation will continue the post-trial access program for patients from previous clinical studies to continue to receive lisavanbulin. Also, the Glioblastoma Foundation will further explore the therapeutic value of lisavanbulin for the treatment of glioblastoma. About lisavanbulin (BAL101553) Lisavanbulin (BAL101553, the prodrug of BAL27862)2, has been investigated as a potential therapy for glioblastoma in clinical phase 1 and 2 studies.3, 4, 5 In preclinical studies, lisavanbulin demonstrated in-vitro and in-vivo activity against diverse treatment-resistant cancer models, including tumors refractory to conventional approved therapeutics and radiotherapy.6, 7, 8 Lisavanbulin efficiently distributes to the brain, with anticancer activity in glioblastoma models.9, 10 The active moiety, BAL27862, binds to the colchicine site of tubulin, with distinct effects on microtubule organization,11 resulting in the activation of the "spindle assembly checkpoint" which promotes tumor cell death.12 Lisavanbulin has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA) for the treatment of malignant glioma (brain cancer), including glioblastoma. About Glioblastoma Foundation The mission of the Glioblastoma Foundation is to transform the standard of care for glioblastoma. It is based in Durham, North Carolina (USA) and supports the development of new drugs and other effective therapies for glioblastoma. Because each glioblastoma is different, it is likely that no one drug will work for everyone, and any therapies for glioblastoma will need to be targeted. The Glioblastoma Foundation supports the development of targeted therapies for glioblastoma. The organization also provides support for patients, and raises awareness of glioblastoma. For more information, please visit glioblastomafoundation.org. About Basilea Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com. Disclaimer This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning Basilea Pharmaceutica Ltd, Allschwil and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd, Allschwil to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd, Allschwil is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. For further information, please contact: Peer Nils Schröder, PhD Head of Corporate Communications & Investor Relations Basilea Pharmaceutica International Ltd, Allschwil Hegenheimermattweg 167b 4123 Allschwil Switzerland Phone +41 61 606 1102 E-mail media_relations@basilea.com investor_relations@basilea.com This press release can be downloaded from . References B. M. Alexander, T. F. Cloughesy. Adult Glioblastoma. Journal of Clinical Oncology 2017 (35), 2402-2409 J. Pohlmann, F. Bachmann, A. Schmitt-Hoffmann et al. BAL101553: An optimized prodrug of the microtubule destabilizer BAL27862 with superior antitumor activity. Cancer Research 2011, 71 (8 supplement), abstract 1347 ClinicalTrials.gov identifier: NCT03250299 ClinicalTrials.gov identifier: NCT02895360; M. Joerger, T. Hundsberger, S. Haefliger et al. Safety and anti-tumor activity of lisavanbulin administered as 48-hour infusion in patients with ovarian cancer or recurrent glioblastoma: a phase 2a study. Investigational New Drugs 2023 (41), 267-275 ClinicalTrials.gov identifier: NCT02490800; J. S. Lopez, S. Häfliger, R. Plummer et al. Evaluation of response-predictive biomarkers for lisavanbulin: A phase II study in patients with recurrent glioblastoma. ESMO Open 2023, Vol 8, 1, Suppl 2, 100941. A. Sharma, A. Broggini-Tenzer, V. Vuong et al. The novel microtubule targeting agent BAL101553 in combination with radiotherapy in treatment-refractory tumor models. Radiotherapy Oncology 2017 (124), 433-438 G. E. Duran, H. Lane, F. Bachmann et al. In vitro activity of the novel tubulin active agent BAL27862 in MDR1(+) and MDR1(-) human breast and ovarian cancer variants selected for resistance to taxanes. Cancer Research 2010, 70 (8 supplement), abstract 4412 F. Bachmann, K. Burger, G. E. Duran et al. BAL101553 (prodrug of BAL27862): A unique microtubule destabilizer active against drug refractory breast cancers alone and in combination with trastuzumab. Cancer Research 2014, 74 (19 supplement), abstract 831 A. Schmitt-Hoffmann, D. Klauer, K. Gebhardt et al. BAL27862: a unique microtubule-targeted agent with a potential for the treatment of human brain tumors. Molecular Cancer Therapeutics 2009, 8 (12 supplement), C233 A. C. Mladek, J. L. Pokorny, H. Lane et al. The novel tubulin-binding 'tumor checkpoint controller' BAL101553 has anti-cancer activity alone and in combination treatments across a panel of GBM patient-derived xenografts. Cancer Research 2016, 76 (14 supplement), abstract 4781 A. E. Prota, F. Danel, F. Bachmann et al. The novel microtubule-destabilizing drug BAL27862 binds to the colchicine site of tubulin with distinct effects on microtubule organization. Journal of Molecular Biology 2014 (426), 1848-1860 F. Bachmann, K. Burger, H. Lane. BAL101553 (prodrug of BAL27862): the spindle assembly checkpoint is required for anticancer activity. Cancer Research 2015, 75 (15 supplement), abstract 3789 Press release (PDF)

孤儿药临床1期引进/卖出临床2期临床结果

2024-06-20

·Pharmaceutical Technology

Basilea sells rights to microtubule drug to Glioblastoma Foundation

Basilea joined an asset purchase agreement for its brain cancer therapy following a negative Phase II study. Credit: Taljat David via Shutterstock. Basilea has signed an asset purchase agreement with the Glioblastoma Foundation for the company’s glioblastoma candidate, lisavanbulin (BAL101553). Under the terms of the deal, Basilea will sell and transfer all rights for lisavanbulin to the charitable organisation for an undisclosed initial purchase cost. In the future, Basilea will continue to take part in any potential commercial partnerships at a fixed double-digit percentage. The Glioblastoma Foundation plans to take over lisavanbuilin’s post-access trial programme, allowing patients from previous clinical studies to continue receiving the drug. The charity will also oversee any further clinical studies investigating the use of lisavanbulin in glioblastoma. Lisavanbulin is a checkpoint inhibitor that binds to tubulin, which blocks the cell cycle and triggers cell death in cancer cells. The company was developing the drug for brain cancer, and the drug even received an US Food and Drug Administration orphan drug designation in 2021 for the treatment of malignant glioma, a type of brain cancer. However, after a disappointing Phase I/II trial (NCT02490800) readout, the Swiss pharmaceutical company decided not to expand the glioblastoma patient cohort for lisavanbulin in 2022. In the open-label study of nine patients with measurable disease at stage one, one patient demonstrated a partial response to lisavanbulin whilst another showed a 44% target lesion area reduction, as per an American Society of Clinical Oncology 2023 abstract. However, despite sustained activity in these subjects, they were unable to meet formal stage transition criteria leading to an early study completion. Glioblastomas are fast-growing brain tumours that are commonly treated through surgery radiotherapy and chemotherapy. According to the American Brain Tumor Association, glioblastomas make up approximately 14% of all primary brain tumors, with 12,000 cases diagnosed each year in the US. See Also: AZD-1705 by AstraZeneca for Dyslipidemia: Likelihood of Approval Sabestomig by AstraZeneca for Crohn’s Disease (Regional Enteritis): Likelihood of Approval In a 20 June press release, Dr Gita Kwatra, the Glioblastoma Foundation’s CEO, said, “We strongly believe that lisavanbulin will be effective in a subset of glioblastoma patients and we are looking forward to initiating clinical trials of lisavanbulin in the US.” The recent announcement marks Basilea’s second publicly declared deal of 2024. In January 2024, the company signed an agreement with Spexis to acquire its preclinical antibiotics programme. Before this, in October 2024, Basilea sought out a partner for its antibiotic ceftobiprole.

孤儿药临床结果临床2期ASCO会议

2024-06-17

·药渡

2024年上半年FDA批准药物或新适应症（上）

来源：药渡撰文：五月编辑：哦呼 FDA在2023年批准了55种新药和34种细胞和基因疗法。本文主要总结了FDA在2024年上半年批准药物或新适应症。 6月10日产品：Ipsen和Genfit的Iqirvo 适应症：原发性胆汁性胆管炎周一，FDA批准了近十年来第一种治疗原发性胆汁性胆管炎（PBC）的新药Iqirvo。PBC是一种罕见的肝病，在美国影响约100,000人，并可能导致肝功能衰竭。 Iqirvo的加速批准是基于发表在《新英格兰医学杂志》上的III期ELATIVE试验的数据。ELATIVE试验表明，与安慰剂联合熊去氧胆酸（UDCA）相比，接受Iqirvo联合UDCA（n=108）治疗的患者达到生化反应的复合主要终点的患者增加了13倍（分别为51%和4%，治疗差异为47%）[1,2]。 6月10日产品：Almirall的Klisyri 适应症：光化性角化病致力于医学皮肤病学的全球制药公司Almirall今天宣布FDA已批准Almirall最近的补充新药申请（sNDA），将Klisyri的使用范围扩大到100 cm2。 Klisyri 是一种微管抑制剂软膏，现已批准以350毫克的包装尺寸进行，是一种为期5天的局部现场治疗，用于治疗面部或头皮的光化性角化病（AK）。该sNDA得到了一项额外的3期、多中心、开放标签、临床安全性研究的支持，该研究涉及美国100多名患者。该研究的主要终点是评估将替巴尼布林应用于成年AK患者面部或秃顶头皮上约100 cm2的视野的安全性和耐受性。该研究显示，对于局部皮肤反应和治疗相关不良事件（AE），结果与在 25cm2区域进行的原始关键试验一致[3]。 6月7日产品：Geron的Rytelo 适应症：骨髓增生异常综合征 Geron Corporation宣布FDA批准其端粒酶抑制剂Rytelo用于骨髓增生异常综合征（MDS）（一组血癌）适应症，受此消息影响，该公司的股价飙升超过30%。Rytelo 专门被批准用于对标准护理治疗红细胞生成刺激剂无反应或不符合条件的输血依赖性贫血MDS患者。该批准是Geron在经营34年后的首次批准，得到了III期IMerge试验数据的支持，其中Rytelo患者在至少24周内的红细胞输注独立性明显高于安慰剂 - 治疗组为28%，安慰剂组为3%。对于那些做出回应的人来说，这种情况中位数持续了1.5年。 6月7日产品：GSK的Arexvy 适应症：呼吸道合胞病毒 6月7日，GSK宣布，FDA批准重组呼吸道合胞病毒（RSV）疫苗Arexvy的适用范围扩大到50-59岁的RSV高危成人。这是首款保护50-59岁高危人群的RSV疫苗。本次扩大适用人群是基于一项III期安慰剂对照、随机研究（NCT05590403）取得的积极结果：50-59岁人群的免疫反应非劣于60岁及以上的人群，达到了主要终点。此外，研究还达到了安全性和免疫原性的二级和三级终点。 5月31日产品：Moderna的mRESVIA 适应症：呼吸道合胞病毒 Moderna公司今天宣布，美国FDA已批准呼吸道合胞病毒（RSV）mRNA疫苗mRESVIA（mRNA-1345）上市，用于保护60岁及以上成年人免受RSV感染引起的下呼吸道疾病（RSV-LRTD），该批准标志着Moderna公司第二项获批的mRNA疫苗。根据新闻稿，mRESVIA是首款以单剂量预充式注射器供应的RSV疫苗。 mRESVIA基于III期ConquerRSV试验获得批准，该试验是一项针对22个国家约37,000名60岁或以上成年人的全球研究，其对RSV下呼吸道疾病的有效率为83.7%。试验中没有发现严重的安全问题。 5月30日产品：BMS的Breyanzi 适应症：套细胞淋巴瘤在本月早些时候获得滤泡性淋巴瘤的批准后，百时美施贵宝的Breyanzi周四获得了FDA对另一个适应症的认可：复发或难治性套细胞淋巴瘤（MCL）。具体而言，Breyanzi 被批准用于既往接受过至少两线全身治疗（包括布鲁顿酪氨酸激酶抑制剂）的MCL患者。该批准得到了TRANSCEND NHL 001的MCL队列结果的支持，其中Breyanzi治疗在目标患者群体中获得了67.6%的完全缓解率。 5月29日产品：Eli Lilly的Retevmo 适应症：RET突变的小儿癌症礼来周三宣布Retevmo获得了加速批准，用于治疗患有RET阳性甲状腺癌和其他携带突变的实体瘤的两岁及以上儿科患者。据Pharmaphorum报道，Retevmo是该类产品中第一种可用于 12 岁以下儿童的药物。 Retevmo此前被授权用于治疗12岁及以上的RET阳性甲状腺癌患者，Retevmo的新批准是基于一项单臂研究，该研究显示总体缓解率为48%，在随访12个月后未达到中位缓解持续时间。 5月29日产品：Tris Pharma的Onyda XR 适应症：注意力缺陷多动障碍周三，Tris Pharma宣布FDA批准了Onyda XR作为第一种用于注意力缺陷多动障碍（ADHD）的非兴奋剂药物，具有液体制剂和夜间给药。 Onyda XR是盐酸可乐定的重新配方，盐酸可乐定于1974年首次被FDA批准用于治疗高血压。可乐定于2010年被批准用于治疗ADHD，品牌名称为 Kapvay，由 Shionogi拥有。 5月29日产品：Teva的Austedo XR 适应症：迟发性运动障碍和亨廷顿舞蹈症 Teva Pharmaceuticals宣布FDA已批准一种新的单粒、每日一次的氘代丁苯那嗪片剂（Austedo XR）给药选择，一种治疗与亨廷顿病（HD）相关的迟发性运动障碍和舞蹈症的药物。氘代丁苯那嗪是一种囊泡单胺转运蛋白2（VMAT2）抑制剂，现在有4种片剂强度（30、36、42 和 48 mg），增加到6 mg、12 mg 和 24 mg 的原始剂量选择。 5月28日产品：Amgen的Bkemv 适应症：阵发性睡眠性血红蛋白尿和非典型溶血性尿毒症综合征今天，FDA批准Bkemv（依库珠单抗-aeeb）作为第一个与Soliris（依库珠单抗）可互换的生物类似药，用于治疗某些罕见疾病。 Bkemv被批准用于以下治疗适应症，这些适应症目前也被批准用于Soliris：治疗阵发性睡眠性血红蛋白尿症（PNH）患者以减少溶血；和治疗非典型溶血性尿毒症综合征（aHUS）患者，以抑制补体介导的血栓性微血管病。 5月16日产品：Amgen的Imdelltra 适应症：小细胞肺癌安进公司周四获得了其首创的双特异性T细胞接合剂Imdelltra的批准，用于治疗广泛期小细胞肺癌（SCLC）。随着FDA的批准，Imdelltra成为第一个用于晚期SCLC的双特异性T细胞接合器疗法。此次加速批准是基于一项针对目标人群中99名患者的II期研究，其中Imdelltra导致40%的总缓解率和9.7个月的中位缓解持续时间。根据美FDA的新闻稿，Imdelltra的标签包含严重或危及生命的细胞因子释放综合征和神经系统毒性的方框警告，包括免疫效应细胞相关神经毒性综合征。 5月1日产品：勃林格殷格翰的Cyltezo 适应症：类风湿性关节炎、克罗恩病、溃疡性结肠炎等周三，FDA批准了勃林格殷格翰的Humira生物仿制药Cyltezo的高浓度和无柠檬酸盐版本，该版本最初于2021年10月获得批准。新批准的剂量为 100 mg/mL，以品牌参考产品的5%折扣出售。 Cyltezo 适用于与Humira相同的所有疾病，包括中度至重度类风湿性关节炎、克罗恩病和溃疡性结肠炎。周三的批准得到了I期伏尔泰-HCLF研究的数据的支持，该研究比较了200名健康志愿者中高浓度和低浓度（50 mg / mL）Cyltezo 制剂的生物利用度。 4月29日产品：辉瑞和Genmab的Tivdak 适应症：宫颈癌 Tivdak最初是由Seagen（已被辉瑞收购）和Genmab合作开发，基于II期innovaTV 204试验中24%的客观缓解率，于2021年9月获得加速批准。近期，FDA将Tivdak的加速批准转化为对化疗后或化疗后进展的复发性或转移性宫颈癌的全面认可。在招募了500多名患者的III期innovaTV 301研究中，与化疗相比，Tivdak显著提高了生存率。2023年10月的一份报告显示，Tivdak可将复发性或转移性宫颈癌患者的死亡风险降低30%；与化疗相比，它还将死亡或疾病恶化的风险降低了33%。没有观察到新的安全信号。 4月29日产品：X4 Pharmaceuticals的Xolremdi 适应症：WHIM综合征周一，FDA批准了X4 Pharmaceuticals的Xolremdi作为WHIM综合征的第一个靶向治疗药物，WHIM综合征是一种非常罕见的免疫缺陷疾病，以其四个特征命名：疣，低丙种球蛋白血症，感染和骨髓细胞增多症。在III期4WHIM试验中，与安慰剂相比，Xolremdi的年化感染率降低了60%；试验受试者每年的感染率低于1例，而安慰剂组为4.5例。随着治疗时间的增加，患者的减少幅度更大。 4月26日产品：辉瑞的Beqvez 适应症：血友病B 近日，FDA批准了辉瑞公司开发的一次性基因疗法Beqvez（fidanacogene elaparvovec），用于治疗18岁或以上中度至重度血友病B成人患者。美国FDA的批准是基于3期临床试验BENEGENE-2的结果。该试验评估了Beqvez在45名中重度血友病B成年男性受试者中的疗效和安全性。根据辉瑞公布的数据，Beqvez使患者的年化出血率降低了71%，年化凝血因子输注率降低了92%。 4月23日产品：Day One Biopharmaceuticals的Ojemda 适应症：小儿低级别胶质瘤周二，Day One宣布FDA已批准第一种用于复发或难治性小儿低级别胶质瘤（pLGG）儿童的药物，该药物具有BRAF融合或重排。据该公司称，这种名为Ojemda的药物也是pLGG唯一允许每周一次治疗方案的全身治疗选择。 4月22日产品：ImmunityBio的Anktiva 适应症：非肌层浸润性膀胱癌周一，FDA批准了ImmunityBio的Anktiva，这是一种用于非肌肉浸润性膀胱癌的同类首创IL-15超级激动剂。Anktiva 将用于卡介苗（BCG）无反应的原位癌患者。它将与卡介苗（BCG）疫苗一起使用，该疫苗传统上用于降低结核病和其他分枝杆菌感染的风险，但长期以来一直被认为可以在膀胱中诱导免疫反应，从而帮助抵抗癌症。 4月18日产品：基因泰克的Alecensa 适应症：非小细胞肺癌周四，FDA批准了基因泰克的Alecensa作为早期间变性淋巴瘤激酶（ALK）阳性非小细胞肺癌患者的首个辅助治疗药物，这些患者已经接受了肿瘤切除术。在一项比较Alecensa辅助治疗与铂类化疗的III期研究中，Alecensa将疾病复发或死亡的风险降低了76%。根据一项探索性分析，患者的中枢神经系统无病生存期也有显着改善。 4月18日产品：武田的Entyvio 适应症：克罗恩病周四，FDA批准了武田Entyvio的皮下（SC）形式，用于静脉注射Entyvio诱导治疗后患有中度至重度活动性克罗恩病（CD）的成人的维持治疗。该批准得到了III期VISIBLE 2研究的支持，该研究显示，与安慰剂组相比，每两周接受108毫克Entyvio SC维持治疗的“具有统计学意义的患者比例”在52周后实现了长期临床缓解；48%的Entyvio患者达到了这一主要终点，而安慰剂对照组的这一比例为34%。 4月11日产品：阿斯利康的Fasnera 适应症：哮喘周四，阿斯利康宣布FDA批准皮下注射IL-5受体阻滞剂Fasnera的扩展适应症，用于6至11岁儿童严重嗜酸性粒细胞性哮喘的附加维持治疗。嗜酸性粒细胞性哮喘是一种严重的形式，是由称为嗜酸性粒细胞的白细胞引起的呼吸系统炎症引起的。据该公司称，Fasnera与人类IL-5受体的α亚基结合，该受体通常在嗜酸性粒细胞和嗜碱性粒细胞的表面表达，触发两种细胞的细胞死亡，同时抑制炎症。 4月8日产品：ViiV Healthcare的Dovato 适应症：HIV ViiV Healthcare的日常HIV片剂Dovato获得了FDA的另一项批准。Dovato将整合酶链转移抑制剂dolutegravir与核苷逆转录酶抑制剂拉米夫定相结合，被批准用于治疗12岁及以上青少年的HIV-1感染，使其成为第一个口服，两种药物，单片方案可用于该患者群体。 4月5日产品：阿斯利康和第一三共的Enhertu 适应症：HER2阳性实体瘤周五，阿斯利康/第一三共宣布Enhertu获FDA加速批准，用于治疗不可切除或转移性HER2阳性（免疫组化[IHC] 3+）实体瘤成年患者，这些患者已接受过先前治疗且缺乏满意的替代治疗选项。该批准得到了II期DESTINY-PanTumor02试验的数据支持，该试验招募了近470名HER2阳性实体瘤患者。中位数为12.75个月后，Enhertu治疗的总体缓解率为37.1%，而缓解持续时间为11.3个月。患者平均存活6.9个月，无疾病进展，总体存活13.4个月。试验参与者患有多种癌症，包括胆道癌、膀胱癌、宫颈癌、胰腺癌和某些罕见肿瘤。 4月5日产品：强生公司和传奇生物的Carvykti 适应症：多发性骨髓瘤强生公司今天宣布FDA已批准Carvykti用于二线治疗复发或难治性多发性骨髓瘤成人患者，Carvykti成为首个也是唯一一个B细胞成熟抗原（BCMA）靶向疗法，被批准用于治疗多发性骨髓瘤患者。此次批准获得了CARTITUDE-4研究的数据支持，在该研究中，Carvykti治疗导致“与两种标准护理方案相比，无进展生存期的无进展生存期具有统计学意义和临床意义的改善”。 4月5日产品：BMS和2seventy Bio的Abecma 适应症：多发性骨髓瘤 BMS和2seventy bio宣布，2024年4月4日，美国食品药品监督管理局（FDA）批准Abecma®（idecabtagene vicleucel;ide-cel）用于治疗既往两种或多种治疗后复发或难治性多发性骨髓瘤成人患者，包括免疫调节剂（IMiD）、蛋白酶体抑制剂（PI）、以及基于KarMMa-3试验结果的抗CD38单克隆抗体。该批准扩大了Abecma的适应症，使其可用于先前两线治疗后暴露于这三类主要治疗（三类暴露）后复发或难治的患者的早期产品线。Abecma作为一次性输注给药，新的推荐剂量范围为300至510 x 106个CAR阳性T细胞。 4月4日产品：Basilea pharmaceutica的Zevtera 适应症：金黄色葡萄球菌血流感染和社区获得性细菌性肺炎 FDA宣布批准Basilea Pharmaceutica公司自研新分子实体药物Zevtera（有效成分：Ceftobiprole Medocaril Sodium）上市。 Zevtera用于治疗金黄色葡萄球菌血流感染（菌血症）（SAB）成人患者（包括右侧感染性心内膜炎患者），急性细菌性皮炎和皮肤结构感染（ABSSSI）成人患者，以及社区获得性细菌性肺炎（CABP）成人和儿童患者（3个月至18岁以下）。 4月2日产品：Vanda Pharmaceuticals的Fanapt 适应症：1型双相情感障碍 Vanda Pharmaceuticals今天宣布，美国FDA已批准其药品Fanapt（iloperidone）片剂用于急性治疗成人1型双相情感障碍（BP-I）相关的躁狂或混合发作。 4月1日产品：阿斯利康的Voydeya 适应症：阵发性睡眠性血红蛋白尿阿斯利康今天宣布其“first-in-class”口服小分子Voydeya获FDA批准，作为标准疗法补体因子C5抑制剂Ultomiris或Soliris的附加疗法，用于治疗阵发性睡眠性血红蛋白尿症（PNH）成人患者的血管外溶血（EVH）状况。此次批准主要基于随机双盲ALPHA关键3期试验的积极结果：Voydeya达到了从基线到第12周血红蛋白变化的主要终点以及所有关键的次要终点，包括避免输血和慢性病治疗功能评估–疲劳（FACIT-Fatigue）评分的变化。以上是FDA在2024年上半年批准的部分药物或新适应症，由于文章篇幅有限，余下内容将在下篇文章中介绍。参考文献 1. FDA Greenlights First Drug in Nearly a Decade for Rare Liver Disease 2. Kowdley. K.V, et al. Efficacy and Safety of Elafibranor in Primary Biliary Cholangitis. NEJM. 2023. DOI: 10.1056/NEJMoa2306185 3. FDA approves Almirall’s Klisyri® (tirbanibulin) for the treatment of actinic keratosis on expanded area of face or scalp up to 100 cm2 专栏作者五月药物化学硕博，国外博士后，现从事药物研发工作，热爱医药行业，愿与各位同行互相学习、进步，共同见证创新药的发展。 *声明：本文仅是介绍医药疾病领域研究进展或简述研究概况或分享医药相关讯息，并非也不会进行治疗或诊断方案推荐，也不对相关投资构成任何建议。内容如有疏漏，欢迎沟通指出！点击下方“药渡“，关注更多精彩内容 CAR-T疗法：临床现状与应用前景解析剧情反转---AD重磅新药距离获批仅差临门一脚 NK细胞疗法：优势与挑战并存，能否精准施治扬长避短？点击蓝字关注我们

临床3期上市批准疫苗基因疗法

100 项与头孢比罗酯钠相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	头孢比罗酯钠	J01DI01	DB14733

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
社区获得性细菌性肺炎	美国	Basilea Pharmaceutica International Ltd.	2024-04-03
右侧感染性心内膜炎	美国	Basilea Pharmaceutica International Ltd.	2024-04-03
皮肤和皮肤结构感染	美国	Basilea Pharmaceutica International Ltd.	2024-04-03
金黄色葡萄球菌菌血症	美国	Basilea Pharmaceutica International Ltd.	2024-04-03
社区获得性肺炎	加拿大	Avir Pharma, Inc.初创企业	2018-03-20
医院获得性肺炎	加拿大	Avir Pharma, Inc.初创企业	2018-03-20

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
传染性皮肤病	申请上市	欧盟	Janssen Pharmaceutical Unlimited Co.	-
软组织感染	申请上市	欧盟	Janssen Pharmaceutical Unlimited Co.	-
新生儿败血症	临床3期	美国	Basilea Pharmaceutica AG	2023-08-06
新生儿败血症	临床3期	保加利亚	Basilea Pharmaceutica AG	2023-08-06
新生儿败血症	临床3期	爱沙尼亚	Basilea Pharmaceutica AG	2023-08-06
新生儿败血症	临床3期	德国	Basilea Pharmaceutica AG	2023-08-06
新生儿败血症	临床3期	拉脱维亚	Basilea Pharmaceutica AG	2023-08-06
新生儿败血症	临床3期	立陶宛	Basilea Pharmaceutica AG	2023-08-06
新生儿败血症	临床3期	波兰	Basilea Pharmaceutica AG	2023-08-06
新生儿败血症	临床3期	斯洛伐克	Basilea Pharmaceutica AG	2023-08-06

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临床结果

适应症

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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


NCT03137173 (FDA_CDER) 人工标引	临床3期	皮肤和皮肤结构感染	679	ZEVTERA 667 mg	蓋繭餘齋鏇艱膚襯選襯(積蓋糧醖糧範鹽範獵製) = 積簾鹹獵構範襯鹽壓醖憲鏇壓蓋膚廠鏇醖壓顧 (網網夢鹽觸築鏇蓋壓糧 ) 更多	积极	2024-04-03
				Vancomycin plus aztreonam	蓋繭餘齋鏇艱膚襯選襯(積蓋糧醖糧範鹽範獵製) = 鑰願鏇範壓艱網齋鬱廠憲鏇壓蓋膚廠鏇醖壓顧 (網網夢鹽觸築鏇蓋壓糧 ) 更多
NCT03138733 (FDA_CDER) 人工标引	临床3期	金黄色葡萄球菌菌血症	387	ZEVTERA	繭鑰齋齋壓遞憲壓網鑰(製廠壓選窪製簾築鹹廠) = 顧選網繭觸積齋鏇夢網糧範構膚網醖淵築餘夢 (餘淵範獵鏇簾醖鹹網製 ) 更多	积极	2024-04-03
				Daptomycin	繭鑰齋齋壓遞憲壓網鑰(製廠壓選窪製簾築鹹廠) = 觸衊願憲網壓構鏇獵膚糧範構膚網醖淵築餘夢 (餘淵範獵鏇簾醖鹹網製 ) 更多
NCT00326287 \| NCT03439124 (FDA_CDER) 人工标引	临床3期	社区获得性细菌性肺炎	-	Ceftobiprole medocaril (Adult Patients)	齋繭鹽膚鹹範遞鹹鹽願(獵衊範蓋壓壓築窪鹽簾) = 襯構範築選選範齋廠積簾範鏇艱網簾獵鹽鏇簾 (醖壓壓顧鑰獵觸淵鬱淵 ) 更多	积极	2024-04-03
				Ceftriaxone with or without Linezolid (Adult Patients)	齋繭鹽膚鹹範遞鹹鹽願(獵衊範蓋壓壓築窪鹽簾) = 膚蓋範憲窪鏇鏇範選積簾範鏇艱網簾獵鹽鏇簾 (醖壓壓顧鑰獵觸淵鬱淵 ) 更多
NCT03138733 (ERADICATE, Pubmed)	临床3期	金黄色葡萄球菌菌血症	390	Ceftobiprole 500 mg IV every 6 hours for 8 days and every 8 hours thereafter	網網遞憲製憲壓積製艱(遞繭構蓋窪齋廠窪願夢) = 遞顧顧鬱鹽醖簾糧繭窪積繭齋範鏇範齋構構鹽 (鑰廠鹽選淵築壓窪遞齋 ) 更多	积极	2023-10-12
				Daptomycin 6 to 10 mg/kg IV every 24 hours plus optional aztreonam	網網遞憲製憲壓積製艱(遞繭構蓋窪齋廠窪願夢) = 窪範鑰夢積範糧糧繭遞積繭齋範鏇範齋構構鹽 (鑰廠鹽選淵築壓窪遞齋 ) 更多
NCT03138733 (CTgov)	临床3期	金黄色葡萄球菌菌血症	390	Daptomycin	網顧鹹淵壓憲鹹糧鹹顧(顧鑰壓製齋鹽獵鑰衊遞) = 醖製願蓋蓋糧壓遞夢構壓選醖窪淵網遞網願襯 (糧顧顧範膚遞窪鹽膚簾, 鏇窪願範簾壓範遞衊餘 ~ 鏇簾窪簾獵製顧鹽醖鏇) 更多	-	2023-05-06
NCT03138733 (ERADICATE, Corporate Publications) 人工标引	临床3期	金黄色葡萄球菌菌血症	390	Ceftobiprole Medocaril Sodium	願蓋鏇蓋壓製願餘餘鹽(艱夢鹽窪顧夢繭餘夢獵) = 簾鏇築簾壓壓願淵願壓簾鬱醖製鹽廠鹹網選積 (選網憲簾鬱願廠淵遞觸 ) 更多	非劣	2022-10-24
				Aztreonam+Daptomycin	願蓋鏇蓋壓製願餘餘鹽(艱夢鹽窪顧夢繭餘夢獵) = 醖製築廠壓壓鹽範鹹範簾鬱醖製鹽廠鹹網選積 (選網憲簾鬱願廠淵遞觸 ) 更多
NCT02527681 \| NCT03439124 (Pubmed \| Pediatr Infect Dis J)	N/A	-	-	Ceftobiprole (Neonates and infants up to 3 months of age)	構製範襯築製醖鏇鏇遞(壓觸鑰鑰獵願膚蓋繭艱) = 齋齋獵築積窪膚構觸襯蓋襯積醖範鏇繭膚構淵 (憲襯襯膚繭廠構鹽鑰遞 ) 更多	-	2021-11-01
				Ceftobiprole (Patients 3 months to 17 years of age)	構製範襯築製醖鏇鏇遞(壓觸鑰鑰獵願膚蓋繭艱) = 壓衊築獵餘齋壓繭夢衊蓋襯積醖範鏇繭膚構淵 (憲襯襯膚繭廠構鹽鑰遞 ) 更多
NCT03137173 (TARGET, Pubmed \| Clin Infect Dis) 人工标引	临床3期	皮肤和皮肤结构感染	679	Ceftobiprole Medocaril Sodium	衊齋淵淵齋築鹽憲願範(築選餘齋願願選廠製繭) = 膚網簾糧範範選觸願遞築顧選廠糧醖艱簾積鹹 (壓製憲廠齋顧窪憲淵鏇 ) 更多	非劣	2021-10-05
				Vancomycin Hydrochloride+Aztreonam	衊齋淵淵齋築鹽憲願範(築選餘齋願願選廠製繭) = 衊窪齋餘願衊衊鏇鹹蓋築顧選廠糧醖艱簾積鹹 (壓製憲廠齋顧窪憲淵鏇 ) 更多
NCT02527681 (CTgov)	临床1期	细菌感染	15	Ceftobiprole (Ceftobiprole PK Population)	築鏇顧鹹構餘積獵糧鏇(顧繭鑰鑰遞繭簾糧襯繭) = 齋繭鹽鬱憲簾醖鬱鏇廠願糧選遞鏇鏇壓廠鏇鏇 (鹹衊壓壓觸顧範壓積製, 鏇蓋範壓願繭繭願艱網 ~ 顧齋衊艱製鹹範壓夢遞) 更多	-	2021-01-06
				Ceftobiprole (Ceftobiprole ITT/Safety Population)	鹹蓋餘醖網選艱鹹齋觸(衊憲鏇淵襯襯鏇願築廠) = 遞夢窪鹹鏇鹽廠築簾鬱餘遞鹹選蓋範選鑰製壓 (鹹襯醖淵觸鹽艱選糧選, 鏇觸蓋鑰醖範壓鏇築壓 ~ 網廠壓範醖糧願獵範繭) 更多
NCT03439124 (Trial 5, CTgov)	临床3期	社区获得性肺炎 \| 医院获得性肺炎	138	ceftobiprole medocaril (Ceftobiprole Medocaril)	艱糧網衊製襯製鑰鏇糧(鹽鹹範醖淵築範選製鏇) = 鏇觸選築網蓋鏇遞遞網獵繭壓膚鬱鑰網廠積簾 (構顧積築願築衊艱壓襯, 窪獵齋獵夢襯窪壓鏇壓 ~ 蓋鹽艱簾製遞積構廠衊) 更多	-	2020-09-11
				IV standard-of-care cephalosporin (IV Standard-of-care Cephalosporin)	艱糧網衊製襯製鑰鏇糧(鹽鹹範醖淵築範選製鏇) = 淵顧廠顧窪願夢憲鹽膚獵繭壓膚鬱鑰網廠積簾 (構顧積築願築衊艱壓襯, 淵淵積憲築簾鹹鹽膚餘 ~ 鹹襯醖遞壓簾膚獵積鬱) 更多