Kayki-Mutlu Gizem, Michel Martin C
Department of Pharmacology, Faculty of Pharmacy, Ankara University, Ankara, Turkey.
Department of Pharmacology, Johannes Gutenberg University, Langenbeckstr. 1, 55118, Mainz, Germany.
Naunyn Schmiedebergs Arch Pharmacol. 2021 May;394(5):839-852. doi: 10.1007/s00210-021-02085-3. Epub 2021 Apr 16.
While the COVID-19 pandemic also affected the work of regulatory authorities, the US Food and Drug Administration approved a total of 53 new drugs in 2020, one of the highest numbers in the past decades. Most newly approved drugs related to oncology (34%) and neurology (15%). We discuss these new drugs by level of innovation they provide, i.e., first to treat a condition, first using a novel mechanisms of action, and "others." Six drugs were first in indication, 15 first using a novel mechanism of action, and 32 other. This includes many drugs for the treatment of orphan indications and some for the treatment of tropical diseases previously neglected for commercial reasons. Small molecules continue to dominate new drug approvals, followed by antibodies. Of note, newly approved drugs also included small-interfering RNAs and antisense oligonucleotides. These data show that the trend for declines in drug discovery and development has clearly been broken.
虽然新冠疫情也影响了监管机构的工作,但美国食品药品监督管理局在2020年总共批准了53种新药,这是过去几十年中获批数量最多的年份之一。大多数新批准的药物与肿瘤学(34%)和神经学(15%)相关。我们根据这些新药所提供的创新水平进行讨论,即首次治疗某种疾病、首次采用新的作用机制以及“其他”情况。有6种药物是首次获批用于某种适应症,15种是首次采用新的作用机制,还有32种属于其他情况。这其中包括许多用于治疗罕见病的药物,以及一些因商业原因此前被忽视的热带病治疗药物。小分子药物在新药批准中继续占据主导地位,其次是抗体。值得注意的是,新批准的药物还包括小干扰RNA和反义寡核苷酸。这些数据表明,药物研发数量下降的趋势已被明显打破。