TB milestone as FDA approves new drug

TB milestone as FDA approves new drug

A true milestone for the TB community has just been reached, with the US FDA approval of pretomanid as part of the new “BPaL” combination regimen for highly resistant forms of TB (BPaL comprises bedaquiline, pretomanid and linezolid). Achieving treatment success in extensively drug-resistant TB (XDR-TB) is incredibly hard, with worldwide survival rates of 34%. Trial data on the BPaL regimen have shown staggering survival rates of 90%, and the regimen consists of oral tablets taken for just 6 months, compared with the current standard of care that includes painful injections for 18 to 24 months.

I warmly congratulate our friends at TB Alliance for this great advance. Pretomanid is only the third new anti-TB drug approved for use by the FDA in more than 40 years, but it is heartening that it is the first to be developed and registered by a not-for-profit organization. To enable prompt regimen selection and reduce delays in starting XDR-TB treatment from months to hours, we are working on rapid diagnostics, including a second-line LPA (line-probe assay) that has already been adopted and swiftly scaled up in India, and an Xpert XDR-TB cartridge that can be used closer to the point-of-care and is shortly going into multi-country trials.


The full TB Alliance press release is available here.

Photo: Current recommended treatment regimen for highly drug-resistant TB (left) versus the BPaL regimen (right)
Photo credit: TB Alliance