FDA Approves New Treatment for Drug-Resistant TB

Pretomanid, a novel compound developed by the non-profit organization, TB Alliance, was approved by the U.S. FDA for treating some of the most drug-resistant forms of tuberculosis (TB). The new drug was approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD pathway) as part of a three-drug, six-month, all-oral regimen for the treatment of people with extensively drug-resistant TB (XDR-TB) or multidrug-resistant TB (MDR-TB) who are treatment-intolerant or non-responsive (collectively "highly drug-resistant TB").
 
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. 

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