Information note on the use of a new agent, bedaquiline, for the treatment of multidrug-resistant tuberculosis
4 January 2013 | Geneva | On December 28, 2012, the U.S. Food and Drug Administration approved bedaquiline, a new therapeutic agent, as part of combination therapy to treat adults with multidrug-resistant tuberculosis when other alternatives are not available. It is acknowledged that currently available data on the safety and efficacy of bedaquiline arise from Phase IIb trials, and that further efficacy and safety data will be needed from rigorously conducted Phase III trial(s). Based on current, publicly-available data on the efficacy and safety of this compound, as well as on supplementary analyses being requested from independent experts, WHO is initiating a review process aimed at developing rapid interim guidance on the potential use of bedaquiline for the treatment of MDR-TB. An expert review meeting will be convened for this purpose at the end of January 2013.