Priority Review Granted for Bedaquiline (TMC207) for Multi-Drug Resistant Tuberculosis
Janssen Research & Development announced that the FDA has granted Priority Review to the New Drug Application (NDA) for bedaquiline (TMC207) as part of combination therapy for the treatment of adult patients with pulmonary, multi-drug resistant tuberculosis (MDR-TB).
The regulatory submission is based on the 24-week data from the Phase 2 clinical development program, which includes an open-labeled study and a controlled, randomized trial that evaluated the safety and efficacy of bedaquline vs. placebo in the treatment of patients with pulmonary MDR-TB in combination with a background regimen.
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.