Janssen submit MAA to the EMA for TMC 207 as treatment for multi-drug resistant Tuberculosis

Janssen Pharmaceuticals has submitted a Marketing Authorisation Application to the EMA seeking conditional approval for the use of the investigational drug TMC 207 (bedaquiline) as an oral treatment as part of combination therapy for pulmonary, multi-drug resistant Tuberculosis (MDR-TB) in adults. The submission is supported by 24-week data from the Phase II clinical development program, which includes an open-label study and a controlled, randomised 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. Janssen also submitted a New Drug Application to the FDA for bedaquiline in June 2012, under priority review status.