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Medicines for Europe - 16th Legal Affairs Conference (June 29-July 1, 2022 - Barcelona, Spain). 欧洲药品-第16届法律事务会议(2022年6月29日至7月1日，西班牙巴塞罗那)。
IF 1.8 4区 医学
Drugs of today Pub Date : 2022-09-01 DOI: 10.1358/dot.2022.58.9.3461260
Monia Tumminello
{"title":"Medicines for Europe - 16th Legal Affairs Conference (June 29-July 1, 2022 - Barcelona, Spain).","authors":"Monia Tumminello","doi":"10.1358/dot.2022.58.9.3461260","DOIUrl":"https://doi.org/10.1358/dot.2022.58.9.3461260","url":null,"abstract":"<p><p>Medicines for Europe held its 2022 annual conference in Sitges, Spain, from June 29 to July 1. Many topics were discussed including future-proofing healthcare systems in the E.U., methods to build a sustainable European ecosystem to incentivize the development of value-added medicines (VAMs), how to reshape national market policies and build a strong European co-operation to prevent shortages. In addition, attendants discussed key challenges and barriers that need to be addressed to ensure the E.U. remains a leader and an innovator in medicines manufacturing, as well as national strategies and practices influencing the sustainability of the biosimilar medicines market and patient access to biological medicines.</p>","PeriodicalId":11397,"journal":{"name":"Drugs of today","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2022-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40357712","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Imeglimin in type 2 diabetes. 2型糖尿病中的依米霉素。
IF 1.8 4区 医学
Drugs of today Pub Date : 2022-09-01 DOI: 10.1358/dot.2022.58.9.3419555
Jessica Huston, Hannah Schaffner, Logan Langley, Blake Skrable, Andrea Ashchi, Jason Berner, Ashwini Gore, Mae Sheikh-Ali, David Sutton, Rebecca Goldfaden
{"title":"Imeglimin in type 2 diabetes.","authors":"Jessica Huston,&nbsp;Hannah Schaffner,&nbsp;Logan Langley,&nbsp;Blake Skrable,&nbsp;Andrea Ashchi,&nbsp;Jason Berner,&nbsp;Ashwini Gore,&nbsp;Mae Sheikh-Ali,&nbsp;David Sutton,&nbsp;Rebecca Goldfaden","doi":"10.1358/dot.2022.58.9.3419555","DOIUrl":"https://doi.org/10.1358/dot.2022.58.9.3419555","url":null,"abstract":"<p><p>Type 2 diabetes mellitus is a chronic disease most often characterized by increased glucose levels. When blood glucose levels are inadequately controlled or left untreated, the result is a variety of microvascular and macrovascular complications. To prevent these outcomes, many medications are available to manage type 2 diabetes mellitus and prevent disease progression. However, most of the medications available to date only target a few of the physiological defects caused by diabetes and may come with side effects that make adherence to the medication improbable. Imeglimin, a medication currently under investigation in the United States and approved in Japan, is a novel, first-in-its-class medication with a mechanism that is currently understood to target multiple pathways to provide glycemic control. This review aims to present and discuss the current clinical and scientific evidence pertaining to imeglimin.</p>","PeriodicalId":11397,"journal":{"name":"Drugs of today","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2022-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40357710","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Amivantamab: a monoclonal EGFR-MET bispecific antibody for EGFR exon 20 insertion in non-small cell lung cancer. Amivantamab:一种用于非小细胞肺癌EGFR外显子20插入的单克隆EGFR- met双特异性抗体。
IF 1.8 4区 医学
Drugs of today Pub Date : 2022-08-01 DOI: 10.1358/dot.2022.58.8.3432777
Yuhao Xie, Qisi Lu, Jing-Quan Wang, Letao Bo, Charles R Ashby, Zhe-Sheng Chen
{"title":"Amivantamab: a monoclonal EGFR-MET bispecific antibody for EGFR exon 20 insertion in non-small cell lung cancer.","authors":"Yuhao Xie,&nbsp;Qisi Lu,&nbsp;Jing-Quan Wang,&nbsp;Letao Bo,&nbsp;Charles R Ashby,&nbsp;Zhe-Sheng Chen","doi":"10.1358/dot.2022.58.8.3432777","DOIUrl":"https://doi.org/10.1358/dot.2022.58.8.3432777","url":null,"abstract":"<p><p>The U.S. Food and Drug Administration (FDA) first approved amivantamab, a monoclonal epidermal growth factor receptor (EGFR)-mesenchymal--epithelial transition factor (MET) bispecific antibody, in May 2021, to treat adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with an insertion mutation in exon 20 of EGFR. The approval of amivantamab represents a targeted therapy for this subtype of advanced NSCLC. In contrast to other drugs that inhibit the tyrosine kinase activity in the protein, EGFR, amivantamab has efficacy in inhibiting EGFR and MET. In this article, we summarize the development of therapeutic drugs for NSCLC, discuss the mechanism of action of amivantamab, review data from clinical trials with amivantamab and suggest future lines of research.</p>","PeriodicalId":11397,"journal":{"name":"Drugs of today","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2022-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40709615","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Abrocitinib in atopic dermatitis: review of the current literature and clinical trials. 阿布替尼治疗特应性皮炎:当前文献和临床试验综述。
IF 1.8 4区 医学
Drugs of today Pub Date : 2022-08-01 DOI: 10.1358/dot.2022.58.8.3408817
Maddalena Napolitano, Luigi Fornaro, Luca Potestio, Gabriella Fabbrocini, Cataldo Patruno
{"title":"Abrocitinib in atopic dermatitis: review of the current literature and clinical trials.","authors":"Maddalena Napolitano,&nbsp;Luigi Fornaro,&nbsp;Luca Potestio,&nbsp;Gabriella Fabbrocini,&nbsp;Cataldo Patruno","doi":"10.1358/dot.2022.58.8.3408817","DOIUrl":"https://doi.org/10.1358/dot.2022.58.8.3408817","url":null,"abstract":"<p><p>Atopic dermatitis (AD) is an inflammatory chronic-relapsing skin disease affecting approximately 15% to 20% of children and 10% of adults in industrialized countries. Both loss of epidermal barrier permeability and immune dysregulation seem to be the most important actors in AD pathogenesis. Several studies have demonstrated the role of Janus kinase (JAK) enzymes in AD pathogenesis suggesting oral and topical JAK inhibitors as new emerging therapies for AD. Among the JAK inhibitors, abrocitinib is an oral JAK1-selective inhibitor. The aim of this study is reviewing current literature about the efficacy and safety of abrocitinib in AD. The literature search was carried out considering the main search engines relating to medical literature and clinical trials. The efficacy and safety of abrocitinib have been confirmed in several studies suggesting this drug as a valuable treatment for moderate to severe AD.</p>","PeriodicalId":11397,"journal":{"name":"Drugs of today","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2022-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40709614","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Melphalan flufenamide for relapsed/refractory multiple myeloma. Melphalan flufenamide治疗复发/难治性多发性骨髓瘤
IF 1.8 4区 医学
Drugs of today Pub Date : 2022-08-01 DOI: 10.1358/dot.2022.58.8.3367680
Omar Nadeem, Maria-Victoria Mateos, Yvonne A Efebera, Agne Paner, Alessandra Larocca, Paula Rodríguez-Otero, Xavier Leleu, Paul G Richardson
{"title":"Melphalan flufenamide for relapsed/refractory multiple myeloma.","authors":"Omar Nadeem,&nbsp;Maria-Victoria Mateos,&nbsp;Yvonne A Efebera,&nbsp;Agne Paner,&nbsp;Alessandra Larocca,&nbsp;Paula Rodríguez-Otero,&nbsp;Xavier Leleu,&nbsp;Paul G Richardson","doi":"10.1358/dot.2022.58.8.3367680","DOIUrl":"https://doi.org/10.1358/dot.2022.58.8.3367680","url":null,"abstract":"<p><p>Despite therapeutic advances and improved patient outcomes in recent years, multiple myeloma (MM) remains a mostly incurable hematologic malignancy. Patients with relapsed/refractory MM (RRMM), especially those with triple-class-refractory disease or poor-prognostic features, have substantially unmet needs for new therapies with novel mechanisms of action. Melphalan flufenamide (melflufen) is the first alkylating peptide-drug conjugate that targets aminopeptidases to show efficacy and manageable safety, in combination with dexamethasone, in patients with RRMM who had received at least 4 prior lines of therapy, including at least 1 immunomodulatory drug, at least 1 proteasome inhibitor and at least 1 anti-CD38 monoclonal antibody, and received accelerated approval by the U.S. Food and Drug Administration (FDA) in early 2021 for use in this patient population. Initial analyses of the phase III OCEAN study data led to melflufen being voluntarily withdrawn from the U.S. market in late 2021, but subsequent analyses have prompted the manufacturer to rescind its voluntary withdrawal to allow further discussions with the U.S. FDA and the regulatory review with the European Medicines Agency (EMA) is also ongoing. Here, we provide a review of the novel mechanism of action and pharmacokinetics of melflufen, as well as key efficacy and safety from clinical studies that supported its initial approval, and discuss the nuances of the OCEAN study data. Melflufen demonstrates the potential of novel peptide-drug conjugates to positively impact the treatment landscape in RRMM.</p>","PeriodicalId":11397,"journal":{"name":"Drugs of today","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2022-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40709617","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 2
Atogepant for migraine. 抗偏头痛药。
IF 1.8 4区 医学
Drugs of today Pub Date : 2022-08-01 DOI: 10.1358/dot.2022.58.8.3408815
Kate Bedrin, Jessica Ailani
{"title":"Atogepant for migraine.","authors":"Kate Bedrin,&nbsp;Jessica Ailani","doi":"10.1358/dot.2022.58.8.3408815","DOIUrl":"https://doi.org/10.1358/dot.2022.58.8.3408815","url":null,"abstract":"<p><p>Atogepant is a selective oral, small-molecule calcitonin gene-related peptide (CGRP) receptor antagonist that has been approved for preventive treatment of migraine. CGRP is a neuropeptide involved in vasodilation and cerebrovascular regulation. CGRP is the most potent vasoactive constituent of the cerebrovascular trigeminal neuronal system and has a key role in migraine. Medications targeting CGRP are being used as migraine preventive and abortive treatments.</p>","PeriodicalId":11397,"journal":{"name":"Drugs of today","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2022-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40709616","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
Molnupiravir for the treatment of COVID-19. 莫努匹拉韦用于治疗COVID-19。
IF 1.8 4区 医学
Drugs of today Pub Date : 2022-07-01 DOI: 10.1358/dot.2022.58.7.3419558
Bela G Santani, Brian W LeBlanc, Ritesh P Thakare
{"title":"Molnupiravir for the treatment of COVID-19.","authors":"Bela G Santani,&nbsp;Brian W LeBlanc,&nbsp;Ritesh P Thakare","doi":"10.1358/dot.2022.58.7.3419558","DOIUrl":"https://doi.org/10.1358/dot.2022.58.7.3419558","url":null,"abstract":"<p><p>Molnupiravir (MK-4482, EIDD-2801) is a promising broad-spectrum experimental antiviral developed by Merck & Co. It is a nucleoside analogue prodrug that undergoes rapid conversion into nucleoside triphosphate (NTP) by intracellular metabolic processes. NTP inhibits viral polymerase by acting as an alternative substrate. Molnupiravir was initially developed to treat influenza and Venezuelan equine encephalitis virus (VEEV) infection as it exerts its antiviral activity by inhibiting RNA-dependent RNA polymerase (RdRp). Currently, it is being developed for the treatment of SARS-CoV-2 infection. Molnupiravir has demonstrated potent in vitro antiviral activity against positive-sense RNA viruses including influenza viruses, SARS-CoV, SARS-CoV-2 and MERS-CoV with low cytotoxicity and a high resistance barrier. Molnupiravir has been evaluated in phase I, II and III trials where it has demonstrated good efficacy, dose-dependent pharmacokinetics and a sound safety profile. In an interim analysis of a phase III study, treatment with molnupiravir reduced the risk of hospitalization or death by 50% in patients with COVID-19; in the final analysis, the reduction was 30%. On the basis of positive results in clinical trials, molnupiravir has been authorized for emergency use by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) and the U.S. Food and Drug Administration (FDA) in adults with mild to moderate COVID-19.</p>","PeriodicalId":11397,"journal":{"name":"Drugs of today","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40534997","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 5
Infigratinib for cholangiocarcinoma. 消炎替尼治疗胆管癌。
IF 1.8 4区 医学
Drugs of today Pub Date : 2022-07-01 DOI: 10.1358/dot.2022.58.7.3408813
Saeed Sadeghi
{"title":"Infigratinib for cholangiocarcinoma.","authors":"Saeed Sadeghi","doi":"10.1358/dot.2022.58.7.3408813","DOIUrl":"https://doi.org/10.1358/dot.2022.58.7.3408813","url":null,"abstract":"<p><p>Cholangiocarcinoma (CCA) is a serious and often fatal cancer of the bile ducts of the liver with a 5-year survival rate of 5-15%. At the time of diagnosis, most patients present with advanced or metastatic CCA, which is an aggressive malignancy with a poor prognosis. The standard of care for patients with locally advanced or metastatic CCA includes systemic chemotherapy with gemcitabine and cisplatin. Recently, research in the molecular basis of cancer has led to the discovery of underlying gene alterations, allowing the development of targeted therapies. Here we provide a review of infigratinib, which is an oral small-molecule tyrosine kinase inhibitor targeting fibroblast growth factor receptor (FGFR). On the basis of positive phase II efficacy data, infigratinib received accelerated approval from the U.S. Food and Drug Administration (FDA) for adults with previously treated, unresectable locally advanced or metastatic CCA with an FGFR2 fusion or other rearrangement.</p>","PeriodicalId":11397,"journal":{"name":"Drugs of today","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40534996","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 3
Update on ozanimod for ulcerative colitis. 奥扎莫德治疗溃疡性结肠炎的最新进展。
IF 1.8 4区 医学
Drugs of today Pub Date : 2022-07-01 DOI: 10.1358/dot.2022.58.7.3408818
Elisabetta K Antonelli, Rachele Del Sordo, Olivia Morelli, Vincenzo Villanacci, Gabrio Bassotti
{"title":"Update on ozanimod for ulcerative colitis.","authors":"Elisabetta K Antonelli,&nbsp;Rachele Del Sordo,&nbsp;Olivia Morelli,&nbsp;Vincenzo Villanacci,&nbsp;Gabrio Bassotti","doi":"10.1358/dot.2022.58.7.3408818","DOIUrl":"https://doi.org/10.1358/dot.2022.58.7.3408818","url":null,"abstract":"<p><p>Treating moderate to severe ulcerative colitis (UC) has been enriched by the increasing number of drugs available for this disease. However, failure of conventional therapies, an incomplete response, or loss of response to biologics is experienced in many UC patients. Thus, there is still a growing need for new drugs in the therapeutic arsenal for UC. Ozanimod is a sphingosine-1-phosphate (S1P) receptor modulator which has been recently approved for UC therapy. In this review, we focus on the mechanism of action of ozanimod hydrochloride in preclinical studies of intestinal inflammation as well as its clinical effectiveness and safety in moderate to severe UC patients. In this population, ozanimod was shown to be significantly more effective than placebo to induce clinical remission. Additionally, in terms of clinical response, corticosteroid-free remission, endoscopic improvement and mucosal healing, ozanimod performed significantly better than placebo in this population. No significant safety concerns about ozanimod emerged from clinical trials in UC.</p>","PeriodicalId":11397,"journal":{"name":"Drugs of today","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40534998","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Contezolid in complicated skin and soft tissue infection. 康替唑胺在复杂皮肤及软组织感染中的应用。
IF 1.8 4区 医学
Drugs of today Pub Date : 2022-07-01 DOI: 10.1358/dot.2022.58.7.3389002
Grace Kaul, Arunava Dasgupta, Sidharth Chopra
{"title":"Contezolid in complicated skin and soft tissue infection.","authors":"Grace Kaul,&nbsp;Arunava Dasgupta,&nbsp;Sidharth Chopra","doi":"10.1358/dot.2022.58.7.3389002","DOIUrl":"https://doi.org/10.1358/dot.2022.58.7.3389002","url":null,"abstract":"<p><p>Contezolid (MRX-I, Youxitai) is an oral oxazolidinone drug being developed by MicuRx Pharmaceutical Co., Ltd., Shanghai, China. It was approved by China's National Medical Products Administration (NMPA) in June 2021, attaining its first approval for the treatment of complicated skin and soft tissue infections (cSSTIs). It is also under clinical development for acute bacterial skin and skin structure infections (ABSSSIs) in the U.S. after receiving qualified infectious disease product (QIDP) classification and fast track status by U.S. Food and Drug Administration (FDA) in September 2018. Contezolid is effective against a broad range of Gram-positive bacteria including activity against methicillin-resistant <i>Staphylococcus aureus</i> (MRSA), penicillin-resistant <i>Streptococcus pneumoniae</i> and vancomycin-resistant Enterococci (VRE). It provides a major benefit over the most popular drug of its class, linezolid (Zyvox), by offering an improved safety profile and minimal effects concerning myelosuppression and monoamine oxidase (MAO) inhibition, two independent adverse events limiting linezolid use in the clinic. The recommended dosage regimen of contezolid is 800 mg every 12 hours for 7-14 days with regular food intake and it can be extended if required. At the mentioned dose under fed conditions, satisfactory efficacy against MRSA with a 90%; or higher cumulative fraction of response and probability of target attainment was achieved. Additionally, contezolid also exhibits activity against <i>Mycobacterium tuberculosis</i> and <i>Mycobacterium abscessus</i>.</p>","PeriodicalId":11397,"journal":{"name":"Drugs of today","volume":null,"pages":null},"PeriodicalIF":1.8,"publicationDate":"2022-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"40518585","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 1
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