Tuberculosis: experts question evidence and safety data used to approve latest drug

Two dozen leading tuberculosis (TB) clinicians and researchers have written to a leading TB charity to question the US’s approval of the antibiotic pretomanid, which was hailed by trialists three months ago as a “watershed” moment.

In August the United States Food and Drug Administration approved pretomanid, the third new anti-TB drug in over 40 years.1 Pretomanid is used alongside bedaquiline and high dose linezolid in the “BPaL regimen,” which is also called Nix-TB when this combination is used for six months.

Francesca Conradie, principal investigator of the trial that supported pretomanid’s application, greeted the announcement by saying that treatment of TB would be measured as before and after pretomanid, much as “the annals of time are measured before and after Christ.”2

Pretomanid was announced as a fast acting oral therapy that improved the success rates of removing drug resistant TB from the sputum of patients after six months from 34% to 89%, citing data submitted to the FDA from the Nix-TB trial.3

The Global Alliance for TB Drug Development (TB Alliance), the not-for-profit innovator of the drug, said that it would haul medieval and toxic treatment of …