Janssen-Cilag International has submitted a Marketing Authorisation Application to the European Medicines Agency (EMA) seeking conditional approval to use 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.
Janssen Infectious Diseases therapeutic area head Wim Parys said MDR-TB is a threat to public health and presents a new treatment challenge in controlling the disease.
"This filing underscores our commitment to discover and develop novel medicines and solutions for serious unmet medical needs, and we hope this new treatment will become an important option for patients with MDR-TB," Parys added.
Bedaquiline kills the bacterium that causes tuberculosis (Mycobacterium tuberculosis, M.tb) by targeting adenosine triphosphate (ATP) synthase, an enzyme that is essential to generate its energy.
Janssen has submitted the drug for regulatory approval on the basis of 24-week data from the phase II clinical development program that evaluated the safety and efficacy of bedaquiline versus placebo to treat patients with pulmonary MDR-TB in combination with a background regimen.
Under priority review status, Janssen submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for bedaquiline in June 2012.
