Pretomanid and the BPaL Regimen
Now included in World Health Organization Guidelines for the Treatment of Drug-Resistant Tuberculosis
Pretomanid was developed by TB Alliance as an oral tablet formulation for the treatment of tuberculosis (TB) in combination with other anti-TB agents. Pretomanid is a new chemical entity and a member of a class of compounds known as nitroimidazooxazines. Novel compounds are important in pursuing new TB treatments because resistance to drugs and drug classes currently used to treat TB is increasingly widespread. During early development, pretomanid was referred to as PA-824. Pretomanid has been clinically studied in more than 1,100 people who participated in 19 clinical trials evaluating the drug’s safety and efficacy. Pretomanid has been clinically studied in 14 countries. Today, more than 40 countries have procured more than 4,000 pretomanid treatment courses.
In August 2019, pretomanid received its first regulatory approval by the U.S. Food and Drug Administration (FDA) as part of a treatment regimen in combination with bedaquiline and linezolid, commonly called BPaL (bee-pal). The regimen was approved for the treatment of patients with highly drug-resistant TB.
Treating Drug-Resistant TB Globally
For the first time, almost all patients with DR-TB can be treated in six months with an all-oral regimen. Based on clinical evidence, the new World Health Organization (WHO) guidelines allow for the programmatic implementation of treating almost all forms of drug-resistant tuberculosis (DR-TB) with either BPaLM (a combination of bedaquiline, pretomanid, linezolid and moxifloxacin) or BPaL (bedaquiline, pretomanid and linezolid).
These updated guidelines allow for the implementation of BPaLM and BPaL regimens under programmatic conditions, stating:
- “WHO suggests the use of a 6-month treatment regimen composed of bedaquiline, pretomanid, linezolid (600 mg) and moxifloxacin (BPaLM) rather than the 9-month or longer (18-month) regimens in MDR/RR-TB patients.”
The guidelines note that:
- “Data from patients in relevant arms of [the TB-PRACTECAL and ZeNix trials] were used in each of the comparisons that led to the conclusions and final recommendation on the use of the BPaLM/BPaL regimen.”