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On December 28, 2012, the FDA approved bedaquiline (Sirturo) as part of combination therapy for multidrug-resistant (MDR) pulmonary tuberculosis (TB) in adults when other alternatives are not available. This drug differs from other TB therapies in its mechanism of action: It inhibits an enzyme required for generation of energy in Mycobacterium tuberculosis.
Bedaquiline was reviewed under the accelerated approval program, which allows the FDA to approve a promising drug based on a surrogate endpoint while additional studies are being conducted to confirm benefit and safety. In this case, accelerated approval was based on phase II studies involving 440 patients. The efficacy surrogate endpoint was faster time to sputum-culture conversion with …