Johnson & Johnson’s Janssen Research & Development unit announced Monday that they have filed a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bedaquiline. If approved, the drug would be the first tuberculosis (TB) countermeasure in over 40 years with a new mechanism of action.
The Janssen TB drug targets adenosine triphosphate synthase, which Mycobacterium tuberculosis requires for generating its energy. Bedaquiline is seeking indications as an oral treatment to be used as part of combination therapy for pulmonary, multi-drug resistant tuberculosis (MDR-TB) in adults. If approved, bedaquiline would also be the first medication intended for treating the resistant forms of TB.
Despite widespread use of an existing vaccine and the availability of several anti-TB drugs, the disease remains a major global health problem. In 2010, 8.8 million people fell ill with TB and 1.4 million died of the disease, according to the World Health Organization. Of those, an estimated 650,000 were cases of MDR-TB. The prevalence of resistant strains is on the rise, and is especially common in Africa and Asia.
A Phase III clinical trial comparing nine months of medication with bedaquiline in contrast with a placebo in about 600 patients is scheduled to begin at the end of 2012. The study will assess the new shorter treatment length of 9 months as compared the current 18 to 24 months recommended by the World Health Organization (WHO).
The company noted that this first filing in the U.S. will be followed by applications in other countries where TB is prevalent.
