Author Affiliations: Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts.
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.
Avorn J. Approval of a Tuberculosis Drug Based on a Paradoxical Surrogate Measure. JAMA. 2013;309(13):1349-1350. doi:10.1001/jama.2013.623