2010年美国FDA批准新药简析

Analysis of new drugs approved by FDA in 2010

2010年美国食品药品监督管理局(FDA)共批准21个新药,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。在FDA批准上市的新药中,迪诺苏单抗(ProliaTM,denosumab)、达比加群酯(Pradaxa,dabigatran etexilate)、芬戈莱默(Gilenya,fingolimod)等新药作用独特或市场前景广阔,颇受关注。2010年上市新药总体数量未见增加,但其中的孤儿药和特色药数量明显增多,生物制品的比重也显著增加,体现出医药产业界研发重心和模式的转变。

The US Food and Drug Administration （FDA） approved 21 new drugs in 2010. In this article, the profile of some exciting products and the trends of drug R＆D was provided. Among the FDA approvals, denosumab （ProliaXM）, dabigatran etexilate （Pradaxa） and fingolimod （Gilenya） are particularly mechanistically interesting or commercially exciting. In 2010, there was not increase in the overall number, but the proportion of orphan drugs and specialty care products increased significantly, and the proportion of biologics raised obviously too, which could suggest the change of focus and mode of drug R＆D.