Drug-resistant or treatment-intolerant or non-responsive multi-drug-resistant tuberculosis - in combination with bedaquiline and linezolid (BPaL regimen)
Development and Regulatory status
Jun 19: US FDA advisory panel recommends approval of pretomanid for treatment of MDR-TB and XDR-TB, in combination with bedaquiline and linezolid. A final decision is expected Q3 2019 .
Apr 19: filed in the US with Priority Review, Marketing Authorisation Application accepted by EMA. TB Alliance has licensed Mylan to manufacture and commercialise pretomanid, on an exclusive basis in high-income countries and a non-exclusive basis on low and medium-income countries .
Mar 15: pretomanid is in development in Southern Africa by the Global Alliance for TB Drug Development; Novartis was the originator and has an option to commercialise the drug in developed countries. The drug has received orphan designation in the EU (EU/3/07/513) and US .
Trial or other data
two PIII trials are currently in progress using the BPaL regimen - NCT02333799 (Nix-TB, initiated March 2015), and NCT03086486 (ZeNix, initiated Q4 2017); both are open-label and will report findings on an ongoing basis at predetermined milestones .
Mar 15: A randomised open-label P3 trial (NCT02342886, STAND) has been initiated: the effect of pretomanid combined with moxifloxacin and pyrazinamide is being tested in varying doses and treatment durations in patients with drug sensitive TB, and for 6 months in multi-drug resistant TB.