2019年4月美国和欧盟新批准药物概述
|
摘要
2019年4月,美国和欧盟共批准22个新药,包括新分子实体、新有效成分、新生物制品、新增适应证及新剂型药物。对全球首次获得批准的新分子实体、新有效成分、新生物制品进行分析,重点介绍这些药物的临床研究结果和研发历史进程。
In April 2019, US Food and Drug Administration(FDA) and European Commission had totally approved 22 new drugs, including new molecular entities, new active ingredient, new biologics and new line extensions(new indications and new formulations). In this article, new molecular entities, new active ingredients and new biologics receiving their first global approval were analyzed with emphasis on the outcomes of clinical trials and development histories.
In April 2019, US Food and Drug Administration(FDA) and European Commission had totally approved 22 new drugs, including new molecular entities, new active ingredient, new biologics and new line extensions(new indications and new formulations). In this article, new molecular entities, new active ingredients and new biologics receiving their first global approval were analyzed with emphasis on the outcomes of clinical trials and development histories.
引文
[1]ADMA Biologics. FDA approves Asceniv?, a novel intravenous immune globulin[EB/OL].(2019-04-01)[2019-04-26]. https://ir.admabiologics.com/press-releases/detail/434/fda-approves-asceniv-anovel-intravenous-immune-globulin.
[2]Wasserman R L, Lumry W, Harris J 3rd, et al. Efficacy, safety, and pharmacokinetics of a new 10%liquid intravenous immunoglobulin containing high titer neutralizing antibody to RSV and other respiratory viruses in subjects with primary immunodeficiency disease[J]. J Clin Immunol, 2016, 36(6):590-599.
[3]Janssen. Balversa?(erdafitinib)receives U.S. FDA approval for the treatment of patients with locally advanced or metastatic urothelial carcinoma with certain FGFR genetic alterations[EB/OL].(2019-04-12)[2019-04-28]. https://www.janssen.com/balversa-erdafitinib-receives-usfda-approval-treatment-patients-locally-advanced-or-metastatic.
[4]Nishina T, Takahashi S, Iwasawa R, et al. Safety, pharmacokinetic, and pharmacodynamics of erdafitinib, a pan-fibroblast growth factor receptor(FGFR)tyrosine kinase inhibitor, in patients with advanced or refractory solid tumors[J]. Invest New Drugs, 2018, 36(3):424-434.
[5]Sanofi. ZynquistaTM now approved in the European Union for treatment of adults with type 1 diabetes[EB/OL].(2019-04-26)[2019-04-30].http://hugin.info/152918/R/2242793/885326.pdf.
[6]Buse J B, Garg S K, Rosenstock J, et al. Sotagliflozin in combination with optimized insulin therapy in adults with type 1 diabetes:the North American inTandem1 study[J]. Diabetes Care, 2018, 41(9):1970-1980.
[2]Wasserman R L, Lumry W, Harris J 3rd, et al. Efficacy, safety, and pharmacokinetics of a new 10%liquid intravenous immunoglobulin containing high titer neutralizing antibody to RSV and other respiratory viruses in subjects with primary immunodeficiency disease[J]. J Clin Immunol, 2016, 36(6):590-599.
[3]Janssen. Balversa?(erdafitinib)receives U.S. FDA approval for the treatment of patients with locally advanced or metastatic urothelial carcinoma with certain FGFR genetic alterations[EB/OL].(2019-04-12)[2019-04-28]. https://www.janssen.com/balversa-erdafitinib-receives-usfda-approval-treatment-patients-locally-advanced-or-metastatic.
[4]Nishina T, Takahashi S, Iwasawa R, et al. Safety, pharmacokinetic, and pharmacodynamics of erdafitinib, a pan-fibroblast growth factor receptor(FGFR)tyrosine kinase inhibitor, in patients with advanced or refractory solid tumors[J]. Invest New Drugs, 2018, 36(3):424-434.
[5]Sanofi. ZynquistaTM now approved in the European Union for treatment of adults with type 1 diabetes[EB/OL].(2019-04-26)[2019-04-30].http://hugin.info/152918/R/2242793/885326.pdf.
[6]Buse J B, Garg S K, Rosenstock J, et al. Sotagliflozin in combination with optimized insulin therapy in adults with type 1 diabetes:the North American inTandem1 study[J]. Diabetes Care, 2018, 41(9):1970-1980.