10 x '20 Progress-Development of New Drugs Active Against Gram-Negative Bacilli: An Update From the Infectious Diseases Society of America

10 x '20 Progress-Development of New Drugs Active Against Gram-Negative Bacilli: An Update From the Infectious Diseases Society of America
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DOI:
10.1093/cid/cit152
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发表时间:
2013-06-15
影响因子:
11.8
通讯作者:
Gilbert, David
Gilbert, David
中科院分区:
医学1区
文献类型:
--
作者:
Boucher, Helen W.;Talbot, George H.;Gilbert, David

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由耐药性细菌,特别是“ESKAPE”病原体引起的感染,频率继续增加,并导致显著的发病率和死亡率。非常需要新的抗微生物剂来治疗由革兰氏阴性杆菌(GNB)引起的感染,所述革兰氏阴性杆菌(GNB)对当前可用的药剂具有抗性。美国传染病协会(IDSA)继续提出立法,监管和资金解决方案,以应对这一持续的危机。本报告更新了截至2013年初美国全身性抗生素的开发和批准状况。自IDSA的2009年管道状态报告以来,只有2种新抗生素被批准,并且每年批准在美国上市的新抗生素数量继续下降。我们确定了7种用于治疗耐药GNB引起的感染的临床开发药物。这些药物都没有被列入我们2009年的抗菌化合物清单中的第2阶段或以后的发展,但不幸的是,没有解决临床相关的GNB耐药性的整个频谱。我们的调查表明,针对耐药GNB引起的感染的新型抗菌药物的开发取得了一些进展,但进展仍然令人担忧地难以捉摸。IDSA强调,我们坚信,抗生素管道问题可以通过全球领导者的合作来解决,以制定创新的激励措施,刺激新的抗菌药物研究和开发。我们的目标是创建一个可持续的全球抗菌药物研发企业,在短期内有能力在2020年之前开发出10种新的、安全有效的全身给药抗生素,这是IDSA“10 x '20倡议”的要求。"
Infections caused by antibiotic-resistant bacteria, especially the "ESKAPE" pathogens, continue to increase in frequency and cause significant morbidity and mortality. New antimicrobial agents are greatly needed to treat infections caused by gram-negative bacilli (GNB) resistant to currently available agents. The Infectious Diseases Society of America (IDSA) continues to propose legislative, regulatory, and funding solutions to this continuing crisis. The current report updates the status of development and approval of systemic antibiotics in the United States as of early 2013. Only 2 new antibiotics have been approved since IDSA's 2009 pipeline status report, and the number of new antibiotics annually approved for marketing in the United States continues to decline. We identified 7 drugs in clinical development for treatment of infections caused by resistant GNB. None of these agents was included in our 2009 list of antibacterial compounds in phase 2 or later development, but unfortunately none addresses the entire spectrum of clinically relevant GNB resistance. Our survey demonstrates some progress in development of new antibacterial drugs that target infections caused by resistant GNB, but progress remains alarmingly elusive. IDSA stresses our conviction that the antibiotic pipeline problem can be solved by the collaboration of global leaders to develop creative incentives that will stimulate new antibacterial research and development. Our aim is the creation of a sustainable global antibacterial drug research and development enterprise with the power in the short term to develop 10 new, safe, and efficacious systemically administered antibiotics by 2020 as called for in IDSA's "10 x '20 Initiative."