十年的FDA批准的药物(2010-2019):趋势和未来的方向

A total of 378 novel drugs and 27 biosimilars approved by the U.S. Food and Drug Administration (FDA) between 2010 and 2019 were evaluated according to approval numbers by year, therapeutic areas, modalities, route of administration, first-in-class designation, approval times, and expedited review categories. From this review, oncology remains the top therapy area (25%), followed by infection (15%) and central nervous system disorders (11%).

监管激励措施已经有效,如孤儿药物的增加以及根据增益法批准的抗菌药物。临床发展时间可能是增加,也许是由于孤儿药物适应症的增加。小分子继续主要粘附在“5”(RO5)参数中,但新型的创新迅速进展,用于反义寡核苷酸(ASO),小干扰RNA(SIRNA)和抗体指向的缀合物(ADC)迅速进展。最后,详细讨论了解决未满足临床临床领域的新的目标和科学突破。

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Dean G. Brown,Heike J. WOBST

j .地中海,化学。 2021. ,64. ,5 ,2312-2338

2021年2月22日

https://doi.org/10.1021/acs.jmedchem.0c01516.
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