Department of Internal Medicine, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.
Department of Biomedical Science, Nazarbayev University School of Medicine, Nur-Sultan, Kazakhstan.
Appl Health Econ Health Policy. 2023 Nov;21(6):831-840. doi: 10.1007/s40258-023-00816-6. Epub 2023 Jul 3.
Drug repurposing is the process of identifying a new use for an existing drug or active substance in an indication outside the scope of the original indication. Drug repurposing has important advantages including reduced development time and costs, and potentially large societal healthcare cost savings. However, current generic drug repurposing research faces a number of challenges in obtaining research funds. Furthermore, regardless of the success of a repurposing trial, commercial parties often lack interest in pursuing marketing authorisation for financial reasons, and academic researchers lack the knowledge, time and funding. Therefore, the new indication of a repurposed drug often does not make it 'on label'. We propose a large increase in public funding for generic drug repurposing research, including funds for the marketing authorisation process when a trial is successful, and a reduction in the regulatory burden of the marketing authorisation process for repurposed generic drugs.
药物重新定位是指在原始适应证范围之外，为现有药物或活性物质确定新适应证的过程。药物重新定位具有重要优势，包括减少开发时间和成本，以及潜在的大量社会效益医疗成本节约。然而，目前通用药物重新定位研究在获得研究资金方面面临诸多挑战。此外，无论重新定位试验是否成功，商业方通常出于财务原因缺乏申请营销许可的兴趣，而学术研究人员则缺乏知识、时间和资金。因此，重新定位药物的新适应证通常无法“标签内”使用。我们建议大幅增加通用药物重新定位研究的公共资金，包括试验成功时的营销许可过程资金，并减少重新定位通用药物营销许可过程的监管负担。
