Aug. 14 (UPI) — The U.S. Food and Drug Administration approved a new antibiotic for highly drug-resistant tuberculosis.
The agency approved the use of pretomanid tablets, developed by global nonprofit TB Alliance, as part of a three-drug regimen for people with extensively drug-resistant, or multi-drug resistant tuberculosis or who are treatment-intolerant or non-responsive.
“Multi-drug resistant TB and extensively drug-resistant TB are public health threats due to limited treatment options,” FDA Principal Deputy Commissioner Amy Abernethy said. “New treatments are important to meet patient national and global health needs.”
There were an estimated 490,000 new cases of multidrug-resistant cases in 2016, according to the World Health Organization.
Pretromain will be used as part of a sixth-month all-oral regimen including bedaquiline and linezolid, collectively referred to as the BPaL regimen.
“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, 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.”
Pretomanid was also the second drug approved under the Limited Population Pathway for Antibacterial and Antifungal Drugs, established by Congress to provide some drugs with a streamlined clinical development program.
The FDA said a test of the regimen on 107 patients it was designed to treat had a success rate of 89 percent.