New drug application filed with FDA for TMC 207 (Janssen Pharmaceuticals) for multi-drug resistant Tuberculosis

Janssen Pharmaceuticals has submitted a New Drug Application to the FDA seeking accelerated approval for the use of TMC 207 (bedaquiline) to be used as part of combination therapy for pulmonary, multi-drug resistant Tuberculosis (MDR-TB) in adults. If approved, it would be the first drug with a new mechanism of action for TB in more than 40 years and the first and only one specifically indicated for MDR-TB. The submission is supported by 24-week data from a Phase II clinical development program, which includes an open-label study and a controlled, randomized trial that evaluated the safety and efficacy of bedaquiline versus placebo in the treatment of patients with pulmonary MDR-TB in combination with a background regimen. A 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.