Aug 15, 2019

FDA approves new cure for deadly strain of drug-resistant TB

A returning patient provides his fingerprint for a biometrics tracking system at an operation ASHA tuberculosis treatment center in 2011, in New Delhi, India. Photo: Andrew Caballero-Reynolds/Getty Images

The Food and Drug Administration on Wednesday approved Pretomanid Tablets, when used alongside 2 other antibiotics, to treat an extremely drug-resistant strain of tuberculosis.

Why it matters: "Tuberculosis has now surpassed AIDS as the world’s leading infectious cause of death," the New York Times reports. The new drug cured 89% of 107 patients with extensively drug-resistant TB after 6 months, when used in combination with antibiotics bedaquiline and linezolid, the FDA said.

What's new: Before the FDA approved this combination therapy, the most common treatment for this type of tuberculosis required patients to take around 30 pills a day plus sometimes daily injections for at least 18 months. This new treatment lowers that dose to 5 pills/day over 6 months for most patients.

  • A spokesperson for the nonprofit TB Alliance, which submitted Pretomanid Tablets to the FDA based on 19 clinical trials, said "it'd be a stretch" to describe previous drug regimens for highly resistant forms of tuberculosis as effective treatment.
  • "We've seen some incremental improvement, but until now, there hasn't been anything I would call a reliable cure," the spokesperson said.

The big picture: XDR-TB, or extensively drug-resistant tuberculosis, is found in over 127 countries. Tuberculosis is especially prevalent in India, South Africa and China. To a lesser extent, Brazil and Russia also have significant TB problems.

  • Tuberculosis is responsible for 1 in 3 HIV deaths, per 2018 data from the World Health Organization.
  • "It happens to be a disease that kills the poorest of the poor," a TB Alliance spokesperson said.

The bottom line: Although the new drug is now approved only in the U.S., FDA approval is a signal to the rest of the world that this treatment has validity.

Go deeper: Experts say eliminating TB is possible this generation, but funding is paramount

Editor's note: This story has been updated to correct 'XDR-TBD' to 'XDR-TB.'

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