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Challenges and opportunities in tuberculosis drug discovery: An industry perspective

机译:结核病药物发现的挑战和机遇:行业观点

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摘要

Tuberculosis (TB) accounts for approximately 2 million deaths every year, mainly affecting the developing world [1,2]. Over the past 40 years, drug-discovery efforts from major pharmaceutical companies have not yielded a single novel drug for TB, further complicating the global health situation due to the increasing resistance of Mycobacterium tuberculosis to the available drug regimens [3]. In recent years, TB drug discovery has been rejuvenated thanks to the efforts from many nonprofit organizations, such as the Global Alliance for TB [4], European Union Frame Work Program and others in collaboration with the pharmaceutical industry [101,102]. It is gratifying to see the recent accelerated approval by the US FDA for Johnson & Johnson's Sirturo? (bedaquiline) [5,103], a diarylquinolone antimycobacterial drug for treating multidrug-resistant TB. This approval has come with a heavy burden for post-marketing studies and it remains to be seen whether the drug will have a significant impact in treating TB patients. Recently, AstraZeneca, in collaboration with the National Institute of Allergy and Infectious Diseases, has launched a mid-stage trial of its investigational TB drug, AZD5847 [6,io4], to determine its effectiveness as a potential new treatment against TB. This editorial aims to provide an insight into different approaches from the viewpoint of the pharmaceutical industry on the discovery of new medicines for TB, focusing on the associated risks and benefits, and highlighting some of the current efforts in this field.
机译:结核病每年造成约200万人死亡,主要影响发展中国家[1,2]。在过去的40年中,大型制药公司的药物发现工作尚未产生一种用于结核病的新药,由于结核分枝杆菌对现有药物方案的耐药性增加,进一步使全球卫生状况复杂化[3]。近年来,由于许多非营利组织的努力,例如全球结核病联盟[4],欧盟框架工作计划以及与制药业合作的其他组织[101,102]的努力,使结核病药物的发现焕然一新。令人欣慰的是,美国食品药品监督管理局最近加快了对强生的Sirturo? (bedaquiline)[5,103],一种用于治疗耐多药结核病的二芳基喹诺酮抗分枝杆菌药物。上市后的研究给这项批准带来了沉重的负担,该药物是否会对结核病患者产生重大影响还有待观察。最近,阿斯利康与美国国家过敏和传染病研究所合作,开始了其研究性结核病药物AZD5847 [6,10]的中期试验,以确定其作为潜在的抗结核新药的有效性。这篇社论旨在从制药行业的观点出发,为结核病新药的发现提供不同方法的见解,着重于相关的风险和益处,并重点介绍该领域目前的一些努力。

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