"This is a critically important milestone in the development of bedaquiline and an important step forward in the development of new treatments for TB," said Mr Wim Parys, MD, head of the infectious diseases therapeutic area at Janssen. "It underscores our commitment to discover and develop novel medicines and solutions for serious unmet medical needs and we hope this new treatment will become an important option for patients with multi-drug resistant TB. This first submission will be followed by others in high-burden countries."

The phase III trial TMC207-C210 a double-blind study comparing nine months of treatment with bedaquiline versus placebo (both with a background regimen) is planned to start recruiting in Q4 2012. This study will evaluate a new regimen of seven drugs for a shorter treatment duration (nine months of treatment) than the current 18 to 24 months WHO standard of care.