Janssen submits bedaquiline NDA

Janssen Research & Development LLC submitted an NDA to FDA for bedaquiline ( TMC207) to treat multi-drug resistant tuberculosis (MDR-TB). Janssen is seeking accelerated approval for bedaquiline based on data from the Phase II TMC207-C208 and TMC207-C209 trials in 394 patients. Janssen, a subsidiary of Johnson & Johnson (NYSE:JNJ), plans to start the Phase III TMC207-C210 trial next quarter. Bedaquiline is a diarylquinoline (DARQ) antibiotic that inhibits mycobacterial F1F0-ATP synthase. Last year, J&J reported data from the second stage of the TMC207-C208 trial showing that in newly diagnosed MDR-TB patients, bedaquiline met the secondary endpoint of a significantly greater proportion of patients who had a negative sputum culture at week 24 vs. placebo (79% vs. 58%, p=0.008). ...