FDA Panel Says Threat of MDR-TB Warrants Fast-Track for New Drugs

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A Food and Drug Administration advisory committee has decided that the threat posed by MDR-TB merits a fast-track approval process for potential new treatments.

The clock is ticking, as drug-resistant TB spreads across the globe and scientists search for new drugs to combat this virulent germ. Given that background, the FDA’s Anti-Infective Drugs Advisory Committee concluded on June 3 that sputum culture conversion could be the basis to support accelerated approval of drugs to treat MDR- TB.

Carol Dukes Hamilton, MD, co-chair of the Center for Global Health Policy’s Scientific Advisory Committee, was among the TB experts urging the FDA committee to approve the fast-track process. Sputum culture conversion is “the best we have” as a surrogate for measuring efficacy in MDR-TB drugs, Hamilton told the panel on Wednesday.

 The FDA panel’s action is a significant step forward for doctors and scientists who are on the front lines of battling the global TB epidemic. According to a story in the Pink Sheet Daily, the advisory committee “supported culture conversion, with improvement/resolution of signs and symptoms, as an acceptable surrogate endpoint for accelerated approval” by an 18-to-1 vote.

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