The drug and vaccine landscape for neglected diseases (2000-11): a systematic assessment
The drug and vaccine landscape for neglected diseases (2000-11): a systematic assessment
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DOI：
10.1016/s2214-109x(13)70078-0
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发表时间：
2013-12-01
影响因子：
34.3
通讯作者：
Bradol, Jean-Herve
中科院分区：
文献类型：
--
作者：
Pedrique, Belen;Strub-Wourgaft, Nathalie;Bradol, Jean-Herve
背景 1975-99 年，只有 1.1% 的新治疗产品是针对被忽视的疾病而开发的。从那时起，一些公共和私人举措试图缓解这种不平衡。我们分析了2000年至2011年被忽视疾病的药物和疫苗的研发管线。方法我们检索了药品监管部门、世界卫生组织和临床试验登记处的数据库，查找2000年1月1日至2011年12月31日之间的条目。我们将被忽视疾病定义为疟疾、结核病、腹泻病、被忽视的热带病（NTD；世界卫生组织的定义）和其他贫困疾病，根据常见病结果 2000-11 年注册的 850 种新治疗产品中，有 37 种（4%）适用于被忽视的疾病，其中包括 25 种具有新适应症或配方的产品以及 8 种疫苗或生物制品。只有 4 个新化学实体被批准用于治疗被忽视的疾病（3 个用于疟疾，1 个用于腹泻病），占研究期间批准的 336 个新化学实体的 1%。截至 2011 年 12 月 31 日登记的 148 445 项临床试验中，只有 2016 年 (1%) 是针对被忽视疾病的。解读 我们的研究结果表明，针对被忽视疾病的药物和疫苗开发持续不足。尽管如此，这些数据和其他数据显示过去 12 年新疗法开发和注册方面略有改善。然而，对于许多被忽视的疾病，迫切需要开发和提供新的治疗产品以改善控制并有可能实现消除。
Background In 1975-99, only 1.1% of new therapeutic products had been developed for neglected diseases. Since then, several public and private initiatives have attempted to mitigate this imbalance. We analysed the research and development pipeline of drugs and vaccines for neglected diseases from 2000 to 2011.Methods We searched databases of drug regulatory authorities, WHO, and clinical trial registries for entries made between Jan 1, 2000, and Dec 31, 2011. We defined neglected diseases as malaria, tuberculosis, diarrhoeal diseases, neglected tropical diseases (NTDs; WHO definition), and other diseases of poverty according to common definitions.Findings Of the 850 new therapeutic products registered in 2000-11, 37 (4%) were indicated for neglected diseases, comprising 25 products with a new indication or formulation and eight vaccines or biological products. Only four new chemical entities were approved for neglected diseases (three for malaria, one for diarrhoeal disease), accounting for 1% of the 336 new chemical entities approved during the study period. Of 148 445 clinical trials registered in Dec 31, 2011, only 2016 (1%) were for neglected diseases.Interpretation Our findings show a persistent insufficiency in drug and vaccine development for neglected diseases. Nevertheless, these and other data show a slight improvement during the past 12 years in new therapeutics development and registration. However, for many neglected diseases, new therapeutic products urgently need to be developed and delivered to improve control and potentially achieve elimination.