FDA panel finds new type of TB drug effective, raising hopes for treatment of drug-resistant strains

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Dr. Dalene von Delft, courtesy David Bryden/RESULTS

Dr. Dalene von Delft had a choice between dying  or going deaf, and that was a choice only if the arduous treatment she was undergoing for drug-resistant tuberculosis worked. The South African pediatrician had contracted a resistant strain of the disease caring for patients, and the only potentially effective treatment was showing one of its predictable and lasting side effects of hearing loss. Although this could end her ability to use a stethoscope, and thus effectively end her career has a doctor, she was better off than many in her country who had run out of treatment options altogether. Then she got a third choice when she became one of only a handful of South Africans to get access to bedaquiline, a new type of treatment for tuberculosis. Cured of tuberculosis and her hearing loss arrested, she has returned to her career.

The very different experiences of other multi-drug resistant tuberculosis patients who do not have access to bedaquiline and for whom existing available treatment is inadequate, are among the reasons tuberculosis treatment advocates are hailing the vote of a U.S. Food and Drug Administration panel earlier this week. The panel voted that bedaquiline is an effective treatment option for adults with multidrug-resistant TB. The findings could be a step toward FDA accelerated approval of the drug by the end of the year, although the same panel was divided on whether data supports the safety of the treatment.

While urging that the drug continue to be tested and monitored for safety, advocates say the treatment has shown fewer side effects than existing treatment, and offers the only hope to patients for whom other treatment options have failed.

“No new drug for TB has been reviewed by the FDA since 1970,” noted Treatment Action Group Executive Director Mark Harrington in his statement before the panel on Wednesday. More than a million people are living with multidrug-resistant tuberculosis, and under current treatment scenarios, 14 million people worldwide will die of tuberculosis in the next decade, he added.

He and other advocates hope that approval of bedaquiline will spur efforts to find more new tuberculosis treatments.

Harrington’s group as well as other global health organizations also are continuing to urge the South African Medicines Control Council to make the drug available for pre-approval access, for patients who have run out options for effective treatment, under the terms through which it briefly became available to Van Delft.

For more on Dr. von Delft’s experience, see this interview by Results Stop TB Advocacy Officer David Bryden.



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