News briefs: TB drug developments at Jansen and AstraZeneca; NPS/Amgen deal amended

US health care giant Johnson & Johnson’s (NYSE: JNJ) Janssen Research & Development unit has submitted a New Drug Application to the US Food and Drug Administration for 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.

If approved by the FDA, bedaquiline 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. Bedaquiline was discovered by scientists at Janssen. Its unique mechanism of action targets adenosine triphosphate (ATP) synthase, which Mycobacterium tuberculosis (M.tb) - the bacterium that causes tuberculosis - requires to generate its energy.

The regulatory submission is supported by 24-week data from the 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.