First novel anti-tuberculosis drug in 40 years

On the last day of 2012, the US Food and Drug Administration (FDA) approved a new drug to treat tuberculosisthe first anti-mycobacterial compound with a novel mechanism of action in 40 years. The agencys go-ahead is for Sirturo (bedaquiline), a diarylquinoline (DARQ) antibiotic, to be dispensed as part of combination therapy in cases of multidrug resistance tuberculosis (MDR-TB) when other alternatives are not available. The accelerated approval was based on phase 2 data from 394 patients (a follow-up phase 3 trial is slated for this year). It marks an important breakthrough for the treatment of MDR-TB and is the first of several other compounds with novel mechanisms progressing in the pipeline.