TB Alliance Announces European Commission Authorisation of New Treatment for Highly Drug-Resistant Tuberculosis

Pretomanid, developed by the non-profit TB Alliance, has received EU marketing authorisation in combination regimen with bedaquiline and linezolid in adults with XDR-TB or treatment-intolerant/non-responsive MDR-TB

PRETORIA, South Africa, Aug. 3, 2020 /PRNewswire/ -- Pretomanid, a novel compound developed by the non-profit organization TB Alliance, has been granted a conditional marketing authorisation by the European Commission (EC) for treating highly drug-resistant forms of pulmonary tuberculosis (TB).¹ The new drug was authorised as part of a three-drug, six month, all-oral regimen for the treatment of adults with extensively drug-resistant TB (XDR-TB) or multidrug-resistant TB (MDR-TB) who are treatment-intolerant or non-responsive.¹

"This regimen provides a new treatment option for patients in the European Union with highly drug-resistant TB infections," said Mel Spigelman, MD, President and CEO of TB Alliance.

The combination treatment of bedaquiline, pretomanid and linezolid – collectively referred to as the BPaL regimen – was studied in the pivotal trial entitled Nix-TB. The multicenter, open-label trial enrolled 109 adults across three sites in South Africa with XDR-TB as well as treatment-intolerant or non-responsive MDR-TB.² The Nix-TB trial demonstrated a favourable outcome in 90% of patients, as published in the 5 March, 2020 issue of the New England Journal of Medicine. 11 patients (10%) had an unfavourable outcome and 98 patients (90%; 95% confidence interval, 83 to 95) had a favourable outcome. The primary efficacy endpoint for the study was the incidence of an unfavourable outcome defined as treatment failure (bacteriologic or clinical) or disease relapse through follow-up until 6 months after the end of treatment. Most patients in Nix-TB were treated with six months of the BPaL regimen. For two patients, treatment was extended to nine months.² The application for this conditional marketing authorisation contains data on 1,168 adults who have received pretomanid in 19 clinical trials that have evaluated the drug's safety and efficacy.³