Pretomanid

Unassigned

New Medicines

Drug-resistant or treatment-intolerant or non-responsive multi-drug-resistant tuberculosis - in combination with bedaquiline and linezolid (BPaL regimen)

Information

New molecular entity
TB Alliance
TB Alliance

Development and Regulatory status

Pre-registration (Filed)
Pre-registration (Filed)
Pre-registration (Filed)
Yes
Yes

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 [5].


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 [3].


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 [1].

Category

Inhibition of cell-wall synthesis; inhibition of protein synthesis
UK incidence is 13.9 per 100,000 population, concentrated in large urban centres and amongst young adults, those from countries with high TB burdens, and those with social risk factors for TB [2].
Drug-resistant or treatment-intolerant or non-responsive multi-drug-resistant tuberculosis - in combination with bedaquiline and linezolid (BPaL regimen)
Oral

Trial or other data

Apr 19: 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 [4].


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. [1]