Medical News and Perspectives
February 6, 2013

MDR-TB Has New Drug Foe After Fast-Track Approval

JAMA. 2013;309(5):430. doi:10.1001/jama.2013.94

The US Food and Drug Administration (FDA) in late December approved the first drug to treat potentially deadly multidrug-resistant tuberculosis (MDR-TB). Bedaquiline, a diarylquinoline antimycobacterial drug, got the go-ahead under the FDA's accelerated approval program for orphan drugs.

MDR-TB “poses a serious health threat throughout the world, and [bedaquiline] provides much-needed treatment for patients who don't have other therapeutic options,” said Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, in a statement.

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