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TAG Testimony to the FDA on New Drug Application for Pretomanid Tablets


On June 6, 2019, TAG submitted testimony to the U.S. Food and Drug Administration (FDA) and the Antimicrobial Drugs Advisory Committee on New Drug Application (NDA) 212862 for pretomanid, proposed as part of a combination regimen with bedaquiline and linezolid (the Nix-TB regimen) in adults for the treatment of pulmonary extensively drug resistant and treatment-intolerant or non-responsive multidrug-resistant tuberculosis (TB). Pretomanid is the first TB drug developed by a non-profit organization.

In its remarks, TAG asks the Antimicrobial Drugs Advisory Committee to consider a number of critical questions regarding the efficacy and safety of pretomanid and the Nix-TB regimen, and suggests further research. TAG also asks the FDA and Antimicrobial Drugs Advisory Committee to ensure that the trade the FDA would be making in approving pretomanid—one of scientific rigor for efficiency in the face of serious unmet medical need—will not set a precedent that lowers the evidentiary standard for future TB drug and drug regimen approvals, thereby doing a disservice to the interests of TB patients in the future.