Janssen-Cilag International NV (Janssen) Submits European Marketing Authorisation Application for Investigational Multi-Drug Resistant Tuberculosis Treatment Bedaquiline

Janssen-Cilag International NV (Janssen) Submits European Marketing Authorisation Application for Investigational Multi-Drug Resistant Tuberculosis Treatment Bedaquiline PR Newswire BEERSE, Belgium, August 31, 2012 BEERSE, Belgium, August 31, 2012 /PRNewswire/ -- 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.