Treating drug-resistant tuberculosis-multidrug resistant TB (MOR-TB) and exclusively drug-resistant TB got a shot in the arm on August 14 approved for use by FDA in more than 40 years. The drug was developed and tested in clinical trials by New York based nonprofit organization TB alliance. TB Alliance has granted a license to Pennsylvania based Mylan to manufacture and commercialize the drug.
Pretomanid drug is expected to be available in the US by the end of this year. TB Alliance has submitted pretomanid as part of the three-drug regimen for drug approval by the European Medicines Agency (EMA). It has also provided data to WHO for consideration of inclusions in treatment guidelines for highly drug-resistant TB.
WHAT MAKES THE NEW DRUG SO PROMISING!
The duration of treatment for drug-resistant TB can be drastically cut from 18-24 months to just 6-9 months when pretomanid drug is used along with 2 already approved drugs- bedaquiniline and linezolid. The all-oral three-drug regimen can also vastly improve the treatment success rate and potentially decrease the number of deaths due to better adherence to treatment.
According to WHO, the treatment success in MDR-TB patients is about 54% while it is just 30% in the case of XDR-TB patients depends on how many other factors-the extents of the drug resistance, the severity of the disease, whether the patient’s immune system is weakened and adherence to treatment.
Drugs used for treating MDR-TB and XDR-TB can cause serious adherence effects such as deafness. The drugs are highly toxic thus reducing adherence to treatment.