EC backs new treatment for highly drug-resistant TB

Pretomanid, a novel compound developed by the non-profit organization TB Alliance, has been granted a conditional marketing authorization by the European Commission (EC) for treating highly drug-resistant forms of pulmonary tuberculosis (TB).

The new drug was authorized as part of a three-drug, six month, all-oral regimen for the treatment of adults with extensively drug-resistant TB (XDR-TB) or multidrug-resistant TB (MDR-TB) who are treatment-intolerant or non-responsive.

The conditional authorization requires the completion of long-term follow-up of patients in the Nix-TB trial as well as completion of TB Alliance’s ZeNix trial, which is evaluating the safety and efficacy of the BPaL regimen with varying doses and durations of the drug linezolid.