The Food and Drug Administration (FDA)’s Antimicrobial Drugs Advisory Committee voted in favor of pretomanid (TB Alliance), as part of a combination regimen with bedaquiline and linezolid, for the treatment of pulmonary extensively drug resistant, treatment intolerant, or nonresponsive multidrug resistant tuberculosis (TB).
The majority of the panel (14 yes, 4 no, 0 abstain) agreed that there was substantial evidence for effectiveness and sufficient evidence for safety of pretomanid, a nitroimidazooxazine antimycobacterial drug. The decision was based on data from 19 clinical trials, as well as interim data from the phase 3 Nix-TB trial (N=109), in which treatment with the combination regimen led to a favorable outcome in 90% of patients (40 of the first 45 patients who completed the 6-month follow-up after the 6-month treatment period). The most common treatment-emergent adverse events reported in the trial were peripheral neuropathy (80% of patients), anemia (37%), and nausea (37%).
The FDA has granted Priority Review to the New Drug Application (NDA) for pretomanid. Although not bound by the committees’ recommendations, the FDA does take them into consideration when making decisions on approval. A Prescription Drug User Fee Act (PDUFA) date of August 2019 has been set for the NDA. If approved, the treatment would be supplied as an immediate-release tablet containing 200mg of pretomanid.
“We are encouraged by the advisory committee’s vote in favor 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,” said Mel Spigelman, president and CEO of TB Alliance. The TB Alliance is a non-profit organization that focuses on developing affordable drug regimens for TB.
For more information visit FDA.gov.