Pretomanid, a compound developed by the non-profit organization TB Alliance, was approved by the U.S. Food & Drug Administration (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 LPAD pathway was established by FDA as a tool to encourage further development of antibacterial and antifungal drugs to treat serious, life-threatening infections that affect a limited population of patients with unmet needs.

 

"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."

 

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 inSouth Africa. The trial enrolled 109 people with XDR-TB as well as treatment-intolerant or non-responsive MDR-TB.

 

Pretomanid is a new chemical entity and a member of a class of compounds known as nitroimidazooxazines. TB Alliance acquired the developmental rights to the compound in 2002. It has been developed as an oral tablet formulation for the treatment of TB in combination with bedaquiline and linezolid, two other anti-TB agents, and is now indicated for use in a limited and specific population of patients.

 

Pretomanid is expected to be available inthe United Statesby the end of 2019. In addition to the U.S. FDA, TB Alliance has submitted pretomanid as part of the BPaL regimen for review by the European Medicines Agency and has provided data to the World Health Organization for consideration of inclusion in treatment guidelines for highly drug-resistant TB.

Pretomanid, developed by the non-profit TB Alliance, has received U.S. approval in combination regimen with bedaquiline and linezolid for people with XDR-TB or treatment-intolerant/non-responsive MDR-TB