Department of Gastroenterology and Hepatology, VU University Medical Center, Amsterdam, The Netherlands.
Department of Gastroenterology and Hepatology, VU University Medical Center, Amsterdam, The Netherlands.
Drug Discov Today. 2018 Jan;23(1):17-21. doi: 10.1016/j.drudis.2017.08.008. Epub 2017 Sep 1.
Identifying new indications for existing drugs creates new therapeutic options while bypassing much of the costs and time involved with bringing a new drug to market. The rediscovery of a generic drug, however, is a challenging pursuit because there is no formal regulatory approach and a lack of economic interest by pharmaceutical companies. This played a part in the re-registration of thioguanine as a rescue drug for the treatment of patients with inflammatory bowel disease in The Netherlands. In this article, we aim to underline the importance of drug rediscovery, the difficulties of this procedure in Europe and we attempt to suggest conceivable solutions.
鉴定现有药物的新适应证可创造新的治疗选择，同时绕过将新药推向市场所涉及的大部分成本和时间。然而，由于没有正式的监管方法，且制药公司缺乏经济利益，因此重新发现一种通用药物是一项具有挑战性的工作。这在荷兰将硫鸟嘌呤重新注册为治疗炎症性肠病患者的抢救药物中发挥了作用。在本文中，我们旨在强调药物再发现的重要性，以及在欧洲进行此程序的困难，并尝试提出一些可行的解决方案。
