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)
Approved (Licensed)
Yes
Yes
Feb 20 · Still under review by EMA.[7]
Aug 19 · Aug 19: U.S. Food and Drug Administration today approved Pretomanid Tablets in combination with bedaquiline and linezolid for the treatment of a specific type of highly treatment-resistant tuberculosis (TB) of the lungs [6].
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
In 2018, there were 4,655 people with TB in England. an 8.2% decline compared to 5,070 in 2017. The number of people in the drug resistant cohort (confirmed or treated as MDR/RR-TB) decreased between 2017 and 2018(62 vs. 47). [8]
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

Feb 20 · PIII trials in progress. [9]
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]