The US Food and Drug Administration (FDA) approved TB Alliance’s pretomanid, a therapy for patients with extensively drug-resistant tuberculosis (TB) or multidrug-resistant TB.
Pretomanid is a compound developed by the non-profit organization TB Alliance and approved under the Limited Population Pathway for Antibacterial and Antifunal Drugs (LPAD) as part of a three-drug, six-month, all-oral regimen.
With this approval, pretomanid will be the third new anti-TB drug approved by the FDA in more than 40 years. It is the first treatment of its kind to be developed and registered by a not-for-profit organization.
The LPAD pathway was established by the FDA to enable further development of antibacterial and antifungal drugs to treat serious life-threatening infections that affect a limited population of patients.
The FDA also granted the drug priority review, qualified infectious disease product, and orphan drug status.
Mel Spigelman, president and CEO of TB Alliance stated, “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.”
According to TB Alliance, the drug is a nitroimidazole, a class of novel antibacterial agents. Pretomanid acts in vitro against all tested drug-resistant clinical isolates and is an active bactericidal and sterilizing agent.
Pretomanid is part of a three-drug regimen that includes the use of bedaquiline and linezolid. The three drugs together can be referred to as the BPaL regimen. This three-drug regimen was studied in a Nix-TB trial across three sites in South Africa in patients with extensively drug-resistant TB, or multi-drug resistant TB.