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In December 2012, bedaquiline (also known by its trade name, Sirturo, or as TMC207) was approved for the treatment of multidrug-resistant tuberculosis (MDR-TB), making it the first drug from a new drug class to treat TB to be approved by the U.S. Food and Drug Administration (FDA) in over 40 years (read more in TAG’s press release and in TAGline). This approval followed an open hearing at the FDA, at which TAG’s executive director, Mark Harrington, gave a statement encouraging the FDA to approve the drug, and to be stringent in requiring further research. In October 2013, the Russian regulatory authority also approved bedaquiline.

Access to the drug is limited, and important research questions remain unanswered, especially as data are available only from phase IIb trials, which raised a concern about mortality. Read more in An Activist’s Guide to Bedaquiline and the 2013 Pipeline Report. In 2012, TAG and the Global Tuberculosis Community Advisory Board (TB CAB) issued an open letter to Janssen, bedaquiline’s sponsor, about the need to accelerate pediatric research, to determine the safety of using bedaquiline and delamanid together, and to support Janssen’s compassionate use program to provide access to bedaquiline for people in urgent need in places where the drug has not yet been approved.

TAG and the TB CAB followed up on these issues with letters to the FDA and the European Medicines Agency. The U.S. National Institutes of Health is now coordinating efforts to determine what further research is necessary to evaluate whether bedaquiline and delamanid are safe to use together, and to conduct any requisite studies. Regarding compassionate use, TAG and the TB CAB supported South African advocates, doctors, and organizations in their call for early access to bedaquiline by sending an open letter to the South African Medicines Control Council (MCC). Though the MCC’s initial response indicated an unwillingness to cooperate bedaquiline is now available for eligible patients at certain centers in South Africa.