TranScrip Partners LLC, Downingtown, Pennsylvania.
Clin Infect Dis. 2015 Dec 1;61 Suppl 6:S678-83. doi: 10.1093/cid/civ819.
Although there was a flurry of new antifungal drugs approved in the early part of the last decade, the growing need for newer agents to treat systemic fungal infections has escalated due to increasing resistance to the 2 main classes of drugs developed to date and shifts in the etiology of these diseases. In addition to this microbial shift, there are more at-risk patients who are being managed in increasingly heroic ways and are thus highly susceptible to these more common resistant fungi and yeasts. However, as we acknowledge the need for new drugs to treat these desperately ill patients, there is a basic problem facing the pharmaceutical industry as it tries to balance the conundrum of antifungal development. Globally there is a relatively low, but growing, number of systemic fungal infections, which creates significant hurdles in conducting clinical trials in a timely and economical manner. In the United States, there have been some significant moves to easing these hurdles and, potentially, to bringing new drugs to the clinic more quickly and efficiently. We will discuss the current unmet clinical need and the current US regulatory positions to encourage further investment in this critical field.
尽管在上个十年的早期出现了大量新的抗真菌药物获得批准，但由于对迄今为止开发的 2 类主要药物的耐药性不断增加以及这些疾病的病因学发生变化，对治疗系统性真菌感染的新型药物的需求不断增加。除了这种微生物变化之外，还有更多高危患者正在以越来越英勇的方式进行治疗，因此非常容易受到这些更为常见的耐药真菌和酵母的影响。然而，尽管我们认识到需要新的药物来治疗这些重病患者，但制药行业在试图平衡抗真菌药物开发的难题时，面临着一个基本问题。全球范围内，系统性真菌感染的数量相对较少，但呈增长趋势，这给及时、经济地进行临床试验带来了重大障碍。在美国，已经采取了一些重大举措来减轻这些障碍，并有可能更快、更有效地将新药推向临床。我们将讨论当前未满足的临床需求以及美国当前的监管立场，以鼓励在这一关键领域进一步投资。
