Graul A I, Pina P, Tracy M, Sorbera L
Clarivate Analytics, Barcelona, Spain.
Drugs Today (Barc). 2020 Jan;56(1):47-103. doi: 10.1358/dot.2020.56.1.3129707.
Highlights of our annual review of new approvals and launches on global drug markets include the approval and launch of Trikafta, the most widely applicable treatment to date for cystic fibrosis; approval of the first Ebola vaccine for general (rather than emergency) use; the pilot rollout in three African countries of the world's first malaria vaccine; approval of a new treatment option for multidrug-resistant bacterial infections; and the approval and launch in China of the first new drug to treat Alzheimer's disease in more than a decade. Several new immune checkpoint inhibitors and antibody-drug conjugates were approved for cancer indications, confirming continued industry enthusiasm for cancer immunotherapy. The most notable trend of 2019 was the granting by the Food and Drug Administration (FDA) of a record number of accelerated approvals, many of which were issued several months ahead of the expected action date.
三联疗法药物Trikafta的批准和上市，这是迄今为止治疗囊性纤维化应用最广泛的疗法；首款用于一般（而非紧急）用途的埃博拉疫苗获批；世界上首款疟疾疫苗在三个非洲国家进行试点推广；一种治疗多重耐药细菌感染的新疗法获批；以及一种治疗阿尔茨海默病的新药在十多年来首次在中国获批并上市。几种新的免疫检查点抑制剂和抗体药物偶联物获批用于癌症适应症，证实了行业对癌症免疫疗法持续的热情。2019年最显著的趋势是美国食品药品监督管理局（FDA）给予了创纪录数量的加速批准，其中许多批准比预期行动日期提前了几个月。
