FDA advisory committee votes favorably on use of pretomanid with bedaquiline and linezolid for drug-resistant TB
TB Alliance press release
On 6 June 2019, the U.S. Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee voted (14 yes, 4 no, 0 abstain) that there is substantial evidence of the effectiveness and sufficient evidence of the safety of pretomanid as part of a combination regimen with bedaquiline and linezolid, in adults for the treatment of pulmonary extensively drug-resistant (XDR) or treatment-intolerant or non-responsive multidrug-resistant (MDR) tuberculosis.
Pretomanid, an investigational anti-TB drug, is the subject of a New Drug Application (NDA) currently under Priority Review by the FDA and a Marketing Authorization Application under review by the European Medicines Agency. It has been developed by TB Alliance, a non-profit drug developer, as part of an all-oral combination therapy known as the BPaL regimen (comprised of bedaquiline, pretomanid and linezolid).
The committee’s vote was based on safety and efficacy data from 19 clinical studies, including an interim analysis of the pivotal phase 3 Nix-TB trial of subjects with XDR-TB or MDR-TB who were treatment-intolerant or non-responsive. A modified intent-to-treat analysis of Nix-TB data included in the regulatory submission indicated that treatment with the BPaL regimen resulted in a favorable outcome in 90 percent of patients after six months of treatment and six months of post-treatment follow-up.
The advisory committee’s non-binding vote is taken into consideration by the FDA as part of its evaluation of the NDA. The Prescription Drug User Fee Act (PDUFA) action date for an FDA decision is in August 2019.
TB Alliance. FDA Advisory Committee votes favorably on the question of the effectiveness and safety of pretomanid in combination with bedaquiline and linezolid for treatment of highly drug-resistant forms of tuberculosis. (06 June 2019).
TB medicine pretomanid enters regulatory review process in the United States.
TB Alliance and Mylan announce global collaboration to commercialise investigational drug pretomanid as part of two regimens to treat tuberculosis.
Antimicrobial Drugs Advisory Committee meeting announcement.