The three-drug regimen consisting of bedaquiline, pretomanid and linezolid – collectively referred to as the BPaL regimen – was studied in the pivotal Nix-TB trial across three sites in South Africa. 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.
"FDA approval of this treatment represents a victory for the people suffering from these highly drug-resistant forms of the world's deadliest infectious disease," said Mel Spigelman, MD, president and CEO of TB Alliance. "The associated novel regimen will hopefully provide a shorter, more easily manageable and highly efficacious treatment for those in need."
"Until very recently, people infected with highly drug-resistant TB had poor treatment options and a poor prognosis," said Dr. Francesca Conradie, principal investigator of the Nix-TB trial. "This new regimen provides hope with 9 out of 10 patients achieving culture negative status at 6 months post-treatment with this short, all-oral regimen."
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. Pretomanid is expected to be available in the United States by the end of this year.