Union welcomes EC authorisation of TB Alliance’s BPaL treatment for drug-resistant TB

The Union welcomes today’s announcement that a new treatment developed by TB Alliance has been approved by the European Commission (EC) for some of the most drug-resistant forms of tuberculosis (TB).

The three-drug, six-month, all-oral regimen has been granted a conditional marketing authorisation by the EC 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).

Last year, following approval by the U.S. Food and Drug Administration (FDA) of TB Alliance’s BPaL treatment, 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.”

Today’s news means that the regimen is now also a new treatment option for people in the European Union with highly drug-resistant TB infections.

As a response to today’s announcement, Grania Bridgen, Director of TB at The Union, said: “This news is very well received as it increases the availability of a new treatment for the worse kinds of TB. In addition, as a consequence of the impact of COVID-19, we are appreciating the need to simplify and shorten TB treatments so that people can complete their treatment quickly and safely.”

“We hope that countries consider implementing pretomanid as part of a BPaL regimen in line with the guidance issued by the World Health Organization (WHO), under operational research conditions, to continue to gather evidence on this new promising treatment.”

Pretomanid is the first ever anti-TB drug developed and registered by a not-for-profit organisation.