FDA advisory panel backs TB Alliance’s tuberculosis regimen

pharmafile | June 10, 2019 | News story | Sales and Marketing FDA, TB Alliance, US, pharma, tuberculosis 

An FDA advisory panel has voted to recommend the investigational drug pretomanid, developed by the non-profit organisation TB Alliance, as a therapy for extensively drug-resistant tuberculosis and treatment-intolerant or non-responsive multidrug-resistant (MDR) tuberculosis, when combined with a regimen of bedaquiline and linezolid.

The US regulator’s Antimicrobial Drugs Advisory Committee voted 14-4 in favour of authorising the drug regimen for application in the US. The panel agreed that there was “substantial evidence of the effectiveness and sufficient evidence of the safety of pretomanid as part of a combination regimen with bedaquiline and linezolid” in the treatment of the condition.

The panel’s decision was made based on aggregated data from 19 clinical studies investigating the safety and efficacy of the pretomanid regimen, one of which incdicated that it achieved a favourable outcome in 90% of patients after six months of treatment and six months of post-treatment follow-up.

“We are encouraged by the advisory committee’s vote in favour of pretomanid for use in combination with bedaquiline and linezolid for the treatment of highly-resistant forms of TB and we look forward to the FDA’s final action,” remarked Mel Spigelman, President and CEO of TB Alliance.

Matt Fellows

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