NiX-TB clinical trial results contribute to FDA approval of new MDR-TB regimen

19 August 2019

The USA's powerful Food and Drug Administration (the FDA) has approved the use of a new drug, Pretomanid, following persuasive results from the NiX-TB trial.

UCL-TB is welcoming news from the USA where the FDA has approved Pretomanid, developed by the non-profit TB Alliance, for use in a combination regimen with bedaquiline and linezolid for people with XDR-TB or treatment-intolerant/non-responsive MDR-TB.

The case for the regimen was submitted using results from the NiX-TB trial. UCL's Centre for Clinical Microbiology provided laboratory management for the trial, and the MRC CTU was responsible for the statistical supervision.