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Janssen Research&Development向美国FDA提交了在研药物bedaquiline(TMC-207)的新药申请(NDA),以寻求加速批准其口服用于联合治疗成人多重耐药肺结核。如果获得FDA批准,本品将成为40多年以来首个具有新作用机制的结核病治疗药物,并且成为惟一一个特别适用于多重耐药肺结核
Janssen Research & Development submitted a New Drug Application (NDA) to the U.S. FDA for investigating the drug bedaquiline (TMC-207), seeking accelerated approval of its oral use for the combined treatment of adult multi-drug resistant pulmonary tuberculosis. With FDA approval, this product will be the first TB treatment drug to have a new mechanism of action in more than 40 years and will be the only one that is uniquely suited for multi-drug resistant TB