PR Newswire (07/02/12)
Janssen Research & Development has submitted a New Drug Application to the U.S. Food and Drug Administration for its investigational drug bedaquiline, which can be used in conjunction with other types of therapy in order to treat adults with pulmonary multi-drug resistant tuberculosis (MDR-TB). The NDA asks the FDA to accelerate its approval of bedaquiline so that the drug can be used to treat MDR-TB orally. Bedaquiline works by targeting adenosine triphosphate (ATP) synthase, which the bacterium that causes TB uses to generate energy. Janssen Research & Development's NDA was supported by 24-week data from the Phase II clinical development program, which consisted of an open-label study and a controlled, randomized trial that examined the effectiveness and the safety of using bedaqualine in treating MDR-TB, compared with a placebo. During the open-label trial, patients were given 400mg of bedaqualine once a day for two weeks, at which point they were given 200mg of the drug three times per week for 22 weeks. At the same time, patients were given an individualized background regimen for MDR-TB, which was followed by continued administration of the background regimen for a year to a year and a half. The results of that study were presented at the 42nd Union World Conference in Lung Health, which was held last year in France.