Médecins Sans Frontières (MSF) has welcomed the approval of pretomanid tablets, in combination with bedaquiline and linezolid, for the treatment of tuberculosis (TB) but has cautioned that the new drug must be affordable to make a real difference.
Last week, the US Food and Drug Administration announced that it had approved the treatment for treating a limited and specific population of adult patients with extensively drug-resistant (XDR), treatment-intolerant or non-responsive multidrug-resistant pulmonary TB.
The three-drug regimen (collectively referred to as the BPaL regimen) had been studied in a trial of 109 patients and was successful in 89 per cent of patients who were evaluated six months after the end of the therapy.
“This newly approved regimen containing pretomanid could be a lifesaver for people with XDR-TB, but it’s not time to celebrate yet,” said Sharonann Lynch, HIV & TB policy advisor for MSF’s Access Campaign. “We now need pretomanid to be registered and available at an affordable price in all countries, prioritising those with the highest TB burden.”
The drug was developed by the TB Alliance, a not-for-profit organisation, which said it has also submitted an application for approval to the European Medicines Agency.