The anti-TB drug Pretomanid got the approval of the US’s Food & Drug Administration (FDA). It is only the third anti-TB drug that got FDA’s approval in more than 40 years.
- The drug Pretomanid will help in fighting multi drug-resistant TB (MDR-TB) and extremely drug-resistant TB (XDR-TB).
- It was developed by a Non-Profit Organisation called TB Alliance.
- The commercial development of the drug has been licensed to Mylan, a Pennsylvania-based company.
- The new drug has many promising features.
- When used along with bedaquiline and linezolid, the already approved anti-TB drugs, Pretomanid can reduce treatment duration of drug-resistant TB from 18-24 months to just six months.
- The three-drug regimen achieved a 91% treatment success rate.
- It has the potential to reduce the number of deaths due to better adherence to treatment.
- As per WHO, the treatment success rates in MDR-TB patients is 54% and XDR-TB patients is 30% with most drugs being ineffective in people with XDR-TB. A combination of eight drugs is needed in a year to treat XDR-TB. Also, these drugs cause side effects like deafness and are toxic.
Prevalence of XDR & MDR-TB
- A TB patient who does not respond to first-line of TB drugs isoniazid and rifampicin have MDR-TB.
- People who are resistant to the first line of drugs and fluoroquinolone and at least one of the three second-line drugs are said to have XDR-TB.
- The Global Tuberculosis Report 2018 of WHO estimates that 4.5 lakh people across the world have MDR-TB and 37,500 people have XDR-TB.
- An estimated 24% of MDR-TB cases are from India and XDR-TB is prevalent in 127 countries.
Who Will Benefit From Pretomanid?
- Pretomanid along with bedaquiline and linezolid is effective at treating adult XDR-TB patients.
- In the case of MDR-TB, the drug can be used only in those who do not respond to normal MDR-TB treatment.
- Also, Pretomanid can be used only for pulmonary TB and not for extra-pulmonary TB, drug-sensitive or latent TB.
Effectiveness Of The Drug Regimen
- The drug regimen is known as BPaL – bedaquiline, pretomanid and linezolid – were trailed across three sites of South Africa.
- For the trial, 109 people with XDR-TB as well as MDR-TB were enrolled. As per TB Alliance, 95 of the first 107 patients were treated with a six-month regimen. The treatment success rate was 90%.
There are many adverse side effects due to the drug regimen. During the trials cases of liver toxicity, testes reduction, blood pH reduction, lower respiratory tract infection, etc. Apart from these, the drug has the potential to treat XDR-TB.