Johnson & Johnson has filed its investigational tuberculosis treatment bedaquiline with regulators in Europe.
The healthcare giant's Janssen unit has submitted a marketing authorisation application to the European Medicines Agency seeking conditional approval for bedaquiline (also known as TMC207). The firm hopes to get the green light for the oral treatment, to be used as part of combination therapy for pulmonary, multi-drug resistant TB in adults.
If approved, bedaquiline could be one of the first drugs with a new mechanism of action for TB in more than 40 years. It would also be one of the first ever to be specifically indicated for MDR-TB.
The antibiotic kills the bacterium that causes tuberculosis by targeting adenosine triphosphate synthase, an enzyme that is essential to generate its energy. The submission is based on Phase II data and a Phase III trial comparing nine months of treatment with bedaquiline versus placebo is planned to start recruiting in the fourth quarter. The study will evaluate a new regimen of seven drugs for a shorter treatment duration (nine months) than the current 18 to 24 months recommended by the World Health Organisation.
Wim Parys, head of infectious diseases at Janssen, said that MDR-TB "is a growing threat to public health and it presents a significant new treatment challenge in controlling this serious and deadly disease". TB is the second most common cause of adult deaths worldwide and kills 1.4 million people per year and although the European region comprises a relatively small percentage of global TB cases, it accounts for a large percentage of the burden of MDR-TB, J&J says.
The company filed bedaquiline with the US Food and Drug Administration in June 2012, under priority review status.