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Pretomanid Gets Panel Endorsement As Part Of Regimen, Not Individual Molecule, For Treatment-Resistant Tuberculosis

 
• By Michael Cipriano

US FDA's Antimicrobial Drugs Advisory Committee made clear that its positive 14-4 approval vote was supportive of the TB Alliance's pretomanid as part of a regimen for treatment-resistant tuberculosis since the role of each active ingredient in the combination is not adequately understood. 

FDA Advisory Committee Feature image
The Antimicrobial Drugs Advisory Committee voted 14-4 supporting approval of the pretomanid regimen.

The US Food and Drug Administration's Antimicrobial Drugs Advisory Committee endorsed the approval of the Global Alliance for TB Drug Development'spretomanid as part of a treatment-resistant tuberculosis regimen in a 14-4 vote, although panelists made clear at the 6 June meeting that they supported the regimen rather than the individual molecule.

Pretomanid is a nitroimidazooxazine antimycobacterial drug which the TB Alliance is developing as part of an oral combination with Janssen Pharmaceutical Cos.'s Sirturo (bedaquiline) and Pfizer Inc

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