FDA approves new oral three-drug regimen for extensively drug-resistant TB

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  1. The US Food and Drug Administration (FDA) has approved new oral three-drug regimen for the extensively-drug resistant tuberculosis (XDR-TB).
  2. The treatment involves Pretomanid tablets in combination with bedaquiline and linezolid, collectively referred to as the BPaL regimen. It has an efficacy rate of 90%. Pretomanid was developed by TB Alliance, a not-for-profit organisation.
  3. Tuberculosis (TB) is an infectious airborne bacterial disease caused by Mycobacterium tuberculosis. It most commonly affects the lungs but can also damage other parts of the body.
  4. There are two TB-related conditions: a) Latent TB – the bacteria remain in the body in an inactive state. They cause no symptoms and are not contagious, but they can become active and b) Active TB – the bacteria do cause symptoms and can be transmitted to others.
  5. When TB infection becomes resistant to the first line of treatment — isoniazid and rifampicin, it is called Multi-drug resistant TB (MDR-TB). Two major reasons for prevalence of MDR TB are: a) mismanagement of TB treatment (incomplete and incorrect treatment) and b) person to person transmission.
  6. Extensively-drug resistant tuberculosis (XDR-TB) is a more serious form of MDR TB. It happens when the infection becomes resistant even to the second-line treatment. It has a mortality rate of 60%.
  7. According to 2018 WHO TB update, there are 1, 14,237 MDR-TB patients globally, of which more than 8,000 are XDR-TB. India has 26,966 MDR-TB patients, the highest in the world, while there are 2,130 XDR-TB patients.