Pretomanid for use in BPaL
In August 2019, TB Alliance received approval from the U.S. Food and Drug Administration (FDA) for pretomanid for the treatment of adults with pulmonary extensively drug-resistant tuberculosis (XDR-TB) and multidrug-resistant TB (MDR-TB) that is treatment-intolerant or non-responsive – these are some of the most highly drug-resistant forms of TB. Pretomanid is approved as part of a three-drug, six-month, all-oral combination regimen with bedaquiline and linezolid (collectively referred to as the BPaL regimen). A Marketing Authorization Application is also under review by the European Medicines Agency for pretomanid and the BPaL regimen.
About Pretomanid and BPaL
Pretomanid is a new chemical entity and a member of a class of compounds known as nitroimidazooxazines. TB Alliance acquired the developmental rights to the compound in 2002. It has been developed as an oral tablet formulation for the treatment of TB in combination with bedaquiline and linezolid, two other anti-TB agents, and is now indicated for use in a limited and specific population of patients. Pretomanid is only the third new anti-TB drug approved for use by FDA in more than 40 years, as well as the first to be developed and registered by a not-for-profit organization.
The BPaL regimen was studied in the pivotal Nix-TB trial across three sites in South Africa. The trial enrolled 109 people with XDR-TB as well as treatment-intolerant or non-responsive MDR-TB. Nix-TB data have demonstrated a successful outcome in 95 of the first 107 patients after six months of treatment with BPaL and six months of post-treatment follow-up.