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[摘要]
2012年美国食品药品监督管理局(FDA)共批准39个新药。在2012年FDA批准上市的新药中,有20个为首创一类新药,其中包括首个直接针对病因治疗囊性纤维化的新型药物依伐卡托;40年来首次获准用于多药耐药性肺结核治疗的贝达喹啉;第1个基于FDA的动物有效性研究原则获准上市的新药瑞西巴库单抗;第1个用于艾滋病相关腹泻,也是第1个获准上市的口服植物药可非雷默。简要介绍其中的重点品种,并就新药研发的现状与趋势进行分析。
[Key word]
[Abstract]
The US Food and Drug Administration (FDA) approved 39 new drugs in 2012. There were 20 first-in-class agents in the 2012 FDA approvals. Particularly noteworthy first-in-class products include ivacaftor, the first cystic fibrosis drug to target the gene defect underlying the disease: bedaquiline, the first new drug to treat multi-drug-resistant pulmonary tuberculosis in the last 40 years; raxibacumab, the first product approved under the FDA’s animal efficacy rule; crofelemer, the first drug approved for HIV-associated diarrhea, and also the first oral botanical drug product. The profile of some exciting products and the trends of drug R&D are provided.
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