Investigational drug pretomanid is under regulatory review by FDA for treatment of XDR-TB and treatment-intolerant or non-responsive MDR-TB as part of a new investigational regimen.
Investigational drug pretomanid, developed by non-profit TB Alliance, is under regulatory review by the U.S. Food and Drug Administration (FDA) for treatment of extensively drug-resistant TB (XDR-TB) and treatment-intolerant or non-responsive multidrug-resistant TB (MDR-TB) as part of a new investigational regimen that includes bedaquiline and linezolid (the Nix-TB regimen). FDA is expected to make a final decision on pretomanid’s approval in August 2019.
On 6 June 2019, TB Alliance announced that the FDA Antimicrobial Drugs Advisory Committee voted (14 yes, 4 no, 0 abstain) that there is substantial evidence of the effectiveness and sufficient evidence of the safety of pretomanid as part of a combination regimen with bedaquiline and linezolid, in adults for the treatment of pulmonary XDR-TB or treatment-intolerant or non-responsive MDR-TB.
The TB Alliance's full press release can be accessed here.
Several testimonies from the public raised concerns and the need for larger, controlled studies of pretomanid and the Nix-TB regimen in people with all forms of drug-resistant TB.
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