Shots:

• The approval is based on the Nix-TB trial assessing bedaquiline- pretomanid and linezolid collectively called BPaL regimen in 109 patients with XDR-TB treatment-intolerant or non-responsive MDR-TB across three sites in South Africa
• The study demonstrated successful outcomes in @6mos. 95/107 patients and for two of the patients the study was extended to nine months. The NDA submission contains data of 1-168 people receiving pretomanid in 19 clinical trials- evaluating its safety and efficacy
• Pretomanid (PO) is an anti-TB drug in combination with bedaquiline + linezolid- and has received Priority Review- Qualified Infectious Disease Product- and Orphan Drug Designation with expected availability in the end of H2’19. Additionally- the company has also submitted to the EMA

Click here to­ read full press release/ article | Ref: TB Alliance | Image: Pharma News