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Widespread Use Of New TB Drug Faces Challenges, Science Reports

The U.S. Food and Drug Administration (FDA) recently approved the drug bedaquiline, which is used to treat multidrug-resistant tuberculosis (MDR-TB) and is the first TB drug to be approved in more than 40 years, “[b]ut the celebration was tempered because sobering challenges face the drug’s widescale use,” Science reports. Bedaquiline, which was granted licensing through an accelerated approval process, must be used in combination with other TB drugs, the magazine notes. “In South Africa and many other countries, MDR patients often start treatment without having the results of drug-sensitivity tests,” and therefore “patients sometimes receive drugs that they are resistant to, [so] adding bedaquiline would be essentially giving monotherapy — and breeding resistance to it,” according to Science. The magazine discusses the history of the drug, the approval process, and potential side effects of the medicine.

“TB researcher Barry Bloom of the Harvard School of Public Health in Boston says several logistical questions loom large,” Science writes, adding, “Given the WHO estimate that 81 percent of the people who have MDR-TB do not know it, how will suppliers determine how much bedaquiline to procure? How should clinicians best combine it with existing TB drugs? Will bedaquiline interfere with drugs to treat HIV or other diseases?” The magazine continues, “As for bedaquiline’s future as a first-line treatment, [drug maker Johnson & Johnson] gave the Global Alliance for TB Drug Development (TB Alliance), a non-profit based in New York City, a royalty-free license to develop and sell it worldwide for that use.” The TB Alliance plans to conduct human trials using bedaquiline and two to three other experimental TB drugs, Science notes (Cohen, 1/11).