Janssen-Cilag International NV (Janssen) today announced it has submitted a Marketing Authorisation Application to the European Medicines Agency (EMA) seeking conditional 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, bedaquiline (Ba-DA-qui-lin) could be one of the first drugs with a new mechanism of action for tuberculosis (TB) in more than 40 years and one of the first ever to be specifically indicated for MDR-TB.
"MDR-TB is a growing threat to public health and it presents a significant new treatment challenge in controlling this serious and deadly disease," said Wim Parys, M.D., Head of the Infectious Diseases therapeutic area at Janssen. "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."
The discovery of bedaquiline (formerly R207910) and its unique mechanism of action were announced in a Science article by scientists at Janssen. The antibiotic 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.
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, randomised 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.