Union welcomes FDA approval of TB Alliance’s BPaL treatment for drug-resistant TB

The Union welcomes today’s announcement that a new treatment developed by the TB Alliance has been approved by the U.S. Food and Drug Administration (FDA) for some of the most drug-resistant forms of tuberculosis (TB). The three-drug, six-month, all-oral regimen has been FDA-approved for the treatment of people with extensively drug-resistant TB (XDR-TB) or multidrug-resistant TB (MDR-TB) who are treatment-intolerant or non-responsive, and includes the new TB drug pretomanid. The three-drug regimen consists of bedaquiline, pretomanid and linezolid (BPaL).

José Luis Castro, Executive Director of The Union, commented: "The Union welcomes a new shorter all-oral regimen for XDR-TB. This represents a step change in the treatment of this severe form of TB, removing injectable agents and shortening the duration from two years to six months. Shorter, more effective regimens such as these are better for people with TB and we emphasise the need that it will be affordable and made available to National TB Programmes to adopt and scale up to offer effective treatment options to people with this severe form of TB.

“The development of pretomanid as part of a new regimen for one of the hardest to treat forms of TB shows the importance of investing in TB research and development.  This investment not only needs to be continued but increased to close the $1.3 billion funding gap as highlighted in Treatment Action Group’s Report on Tuberculosis Research Funding Trends. We hope that with continued increased investment, this will be the first of many new regimens improving the outcomes for people with TB."

This is only the third new anti-TB drug approved for use by the FDA in more than 40 years and is the first ever anti-TB drug developed and registered by a not-for-profit organisation.