Adis, Auckland, New Zealand.
Drugs. 2014 Jun;74(9):1041-5. doi: 10.1007/s40265-014-0241-5.
Delamanid, a nitro-dihydro-imidazooxazole derivative, has been developed by Otsuka Pharmaceutical for the treatment of multidrug-resistant tuberculosis (MDR-TB). Delamanid received its first global approval for the treatment of MDR-TB in the European Union (EU), for use in combination with optimised background therapy. It is also under review for marketing in Japan for MDR-TB, the first drug application filed in Japan for this indication. Delamanid has been granted orphan drug status in both the EU and Japan. This article summarizes the milestones in the development of delamanid leading to this first approval for MDR-TB.
德拉马尼（Delamanid）是一种硝基二氢咪唑恶唑衍生物，由大冢制药公司研发，用于治疗耐多药结核病（MDR-TB）。德拉马尼在欧盟（EU）获得了第一个针对 MDR-TB 的全球批准，可与优化背景治疗联合使用。它也正在日本审查用于 MDR-TB 的上市许可，这是在日本针对该适应症提交的第一个药物申请。德拉马尼在欧盟和日本均被授予孤儿药地位。本文总结了德拉马尼开发过程中的重要里程碑，最终促成了这一针对 MDR-TB 的首次批准。
