Janssen Research & Development announced it has submitted a New Drug Application (NDA) to the FDA seeking accelerated approval for the use of the investigational drug bedaquiline (TMC207) as an oral treatment, to be used as part of combination therapy for pulmonary, multi-drug resistant tuberculosis (MDR-TB) in adults.
The regulatory submission is supported by 24-week data from the Phase 2 clinical development program, which includes an open-label study and a controlled, randomized trial that evaluated the safety and efficacy of bedaquiline vs. placebo in the treatment of patients with pulmonary MDR-TB in combination with a background regimen.
One of the Phase 2 studies in patients with MDR-TB, TMC207-C208 was conducted in two independent stages: Stage 1 was a controlled, randomized, exploratory trial and Stage 2 was a controlled, randomized superiority trial in MDR-TB patients. Stage 2 compared time to culture conversion following the use of bedaquiline (400mg once daily for two weeks followed by 200mg three times a week for 22 weeks) vs. placebo in combination with a standardized background regimen for MDR-TB. The study enrolled 161 patients who received treatment for 24 weeks followed by continuation of the background therapy for an additional 12–18 months.
The submission is further supported by 24-week data from TMC207-C209, the open-label trial in MDR-TB patients, in which bedaquiline was administered as 400mg once daily for two weeks followed by 200mg three times weekly for 22 weeks in combination with an individualized background regimen for MDR-TB, followed by continued administration of the background regimen for 12–18 months. A total of 233 patients from 11 countries were enrolled in the trial, designed to evaluate the safety and efficacy of bedaquiline in treatment-experienced patients, including 25% with pre-extensively drug-resistant TB (pre-XDR) and 21% with XDR-TB.
Bedaquiline targets adenosine triphosphate (ATP) synthase, which Mycobacterium tuberculosis (M.tb)–the bacterium that causes tuberculosis–requires to generate its energy.
For more information visit www.janssenrnd.com.