A Decade of FDA-Approved Drugs (2010-2019): Trends and Future Directions
A Decade of FDA-Approved Drugs (2010-2019): Trends and Future Directions
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DOI：
10.1021/acs.jmedchem.0c01516
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发表时间：
2021-02-22
影响因子：
7.3
通讯作者：
Wobst, Heike J.
中科院分区：
文献类型：
--
作者：
Brown, Dean G.;Wobst, Heike J.
根据按年份、治疗领域、模式、给药途径、首创认定、批准时间和加急审评类别划分的批准数量，对 2010 年至 2019 年间美国食品药品监督管理局 (FDA) 批准的总共 378 个新药和 27 个生物类似药进行了评估。从本次审查来看，肿瘤学仍然是最主要的治疗领域（25%），其次是感染（15%）和中枢神经系统疾病（11%）。根据 GAIN 法案批准的孤儿药和抗菌药物的增加证明了监管激励措施是有效的。临床开发时间可能会增加，这可能是孤儿药适应症增加的结果。小分子仍然主要遵循“5 规则”(Ro5) 参数，但随着反义寡核苷酸 (ASO)、小干扰 RNA (siRNA) 和抗体导向缀合物 (ADC) 的批准，新模式的创新正在迅速进展。最后，详细讨论了解决未满足临床需求领域的新目标和科学突破。
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%). Regulatory incentives have been effective as evidenced by an increase in orphan drugs as well as antibacterial drugs approved under the GAIN act. Clinical development times may be increasing, perhaps as a result of the increase in orphan drug indications. Small molecules continue to mostly adhere to "Rule of 5" (Ro5) parameters, but innovation in new modalities is rapidly progressing with approvals for antisense oligonucleotides (ASO), small-interfering RNA (siRNAs), and antibody-directed conjugates (ADCs). Finally, novel targets and scientific breakthroughs that address areas of unmet clinical need are discussed in detail.