FDA Antimicrobial Drugs Advisory Committee recommends approval of pretomanid

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.

You can download here:

  1. Treatment Action Group (TAG) testimony
  2. Global TB Community Advisory Board (TB CAB) testimony
  3. U.S. National TB Controllers Association (NTCA) testimony
  4. Dr. Jennifer Furin, Harvard Medical School, Department of Global Health and Social Medicine, testimony

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By TB Alliance, TB advocates

Published: June 9, 2019, 9:43 p.m.

Last updated: June 10, 2019, 8:57 p.m.

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