TB Alliance announced the FDA has approved pretomanid, a new drug developed to treat Extensively Drug-Resistant Tuberculosis (XDR-TB) and provide treatment for intolerant/non-responsive Multidrug-Resistant (MDR) TB. The 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. The three-drug regimen, consisting of bedaquiline, pretomanid and linezolid (the BPaL regimen), was studied in the pivotal Nix-TB trial.
The Nix-TB trial was conducted 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 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. For two patients, treatment was extended to nine months. Adverse reactions reported during the Nix-TB trial included hepatotoxicity, myelosuppression, peripheral and optic neuropathy.
TB Alliance acquired the license to pretomanid, then known as Pa-824, in 2002.
Pretomanid was granted Priority Review, Qualified Infectious Disease Product, and Orphan Drug status.
Tuberculosis is an infectious bacterial disease characterized by the growth of nodules (tubercles) in the tissues, especially the lung. It is an airborne disease that can be spread by coughing or sneezing. Tuberculosis is found in every country in the world. It is the leading infectious cause of death worldwide. In 2017, 10 million people fell ill from active TB and 1.6 million died. There are more than half a million cases of MDR-TB annually, with about 6% of those cases being XDR-TB. Current WHO figures report that 127 countries have reported cases of XDR-TB. Drug-resistant forms of TB currently accounts for close to 1 in 3 deaths due to antimicrobial resistance annually.
Pretomanid Tablet is a nitroimidazooxazine antimycobacterial drug. Pretomanid kills actively replicating M. tuberculosis by inhibiting mycolic acid biosynthesis, thereby blocking cell wall production. Under anaerobic conditions, against non-replicating bacteria, pretomanid acts as a respiratory poison following nitric oxide release.