This Position Statement by the World Health Organization (WHO) on the use of delamanid in the treatment of multidrug-resistant tuberculosis (MDR-TB) has been developed in response to the final data from the phase III, multicentre, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of delamanid (Trial #242-09-213, hereafter referred to as ‘Trial 213’). The final Trial 213 data were released in late November by the manufacturer (Otsuka Pharmaceutical, Japan) to WHO and to the European Medicines Authority (EMA) in compliance with EMA regulatory requirements. The original trial protocol and subsequent amendments are registered (#NCT0142670) in the US/NIH clinical trials register (https://clinicaltrials.gov/ct2/show/NCT01424670).
WHO conducted an expedited external expert review of the data on Trial 213 data in early December 2017 in order to assess the implications of the results on the 2014 and 2016 interim policy guidance. As data from ongoing observational studies using delamanid are not yet available for review, this document is focused on the results of Trial 213 and its immediate policy implications.
To download and read the position statement, click here.