Policy & Regulation
RTI International wins FDA approval for pretomanid for treating drug-resistant TB
15 August 2019 -

Research company RTI International reported on Wednesday the receipt of approval from the US Food and Drug Administration (FDA) for the new drug pretomanid for treating Extensively Drug-Resistant Tuberculosis (XDR-TB) and intolerant/non-responsive Multidrug-Resistant (MDR) TB under partnership with the National Institute of Allergy and Infectious Diseases (NIAID) and TB Alliance.

In conjunction with the FDA approval, TB Alliance has negotiated licence agreements enabling an affordable cost of pretomanid in low resource countries.

Pretomanid , also known as Pa-824, is only the third anti-TB drug approved by FDA in more than 40 years. The six-month, all-oral BPaL (bedaquiline and linezolid) regimen cured nine out of ten participants of the XDR-TB patients in the trials conducted in South Africa. RTI scientist Doris Rouse led institute work to develop the treatment with a success rate of 89%.

XDR-TB is resistant to four of the main drugs, including injectable agents, currently used to treat drug resistant TB around the world.

TB Alliance is now targeting adoption and availability of pretomanid as part of the BPaL regimen in countries with a high unmet need for XDR-TB treatments.