Janssen-Cilag files for EU approval of bedaquiline in MDR-TB

2 September 2012

Johnson & Johnson (NYSE: JNJ) Belgium-based subsidiary Janssen-Cilag International submitted a Marketing Authorization Application to the European Medicines Agency on Friday, 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 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, says Janssen.

Likely to come to market before delamanid and PA-824

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