Simsek M, de Boer N K H, Mulder C J J
VUmc, afd. Maag-, darm- en leverziekten, Amsterdam.
Ned Tijdschr Geneeskd. 2018;162:D1757.
Continued development of existing drugs ('drug rediscovery') may offer new therapeutic options and be cost-effective. Rediscovered drugs are commonly prescribed off-label, although licensing can be important to allow safe and controlled prescription of the drugs to patients. Licensing of a new indication for a generic drug, however, is a complicated process since there is no blueprint for this and there is little interest from the pharmaceutical industry due to an unattractive cost-recovery model. In this article, we illustrate the successful license-extension for thioguanine - initially developed in 1950 for leukaemia - as a new treatment for patients with inflammatory bowel disease.
现有药物的持续研发（“药物再发现”）可能会提供新的治疗选择且具有成本效益。重新发现的药物通常是超说明书用药，不过许可对于向患者安全且可控地开具这些药物很重要。然而，为仿制药的新适应症发放许可却是一个复杂的过程，因为没有相关蓝本，而且由于成本回收模式缺乏吸引力，制药行业对此兴趣不大。在本文中，我们阐述了硫鸟嘌呤（最初于1950年研发用于治疗白血病）成功获批许可用于治疗炎症性肠病患者这一案例。
