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April 3, 2013

Approval of a Tuberculosis Drug Based on a Paradoxical Surrogate Measure

Author Affiliations

Author Affiliations: Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.

JAMA. 2013;309(13):1349-1350. doi:10.1001/jama.2013.623

On December 31, 2012, the US Food and Drug Administration (FDA) announced its approval of a new drug to treat multidrug-resistant tuberculosis (MDR-TB). The agency granted bedaquiline (Sirturo) “fast-track” approval, assessing its efficacy by a surrogate measure rather than an actual clinical outcome. The criterion was the capacity of the drug, compared with placebo, to convert a patient's sputum culture from positive to negative for Mycobacterium tuberculosis when added to a standard MDR-TB regimen.

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