WHO has started preparations for a rapid review of its interim guidance on the use of delamanid in the treatment of patients with multidrug-resistant tuberculosis (MDR-TB). This follows the release of the phase III randomised control trial results by Otsuka Pharmaceutical at the 48th UNION World Conference on Lung Health on 13 October.
In line with WHO requirements an independent Guideline Development Group is being convened to assess all currently available data on delamanid and to advise WHO on policy implications. WHO is therefore calling for the manufacturer, researchers and end-users of delamanid to provide data from relevant studies for this review at the earliest opportunity.
The final outcomes of the WHO review of delamanid are expected to become available by early 2018. In addition, a comprehensive review of all WHO guidance on MDR-TB treatment is currently planned for mid-2018, which will include the final results from the STREAM trial on the shorter MDR-regimen expected in late April 2018.
Background
In November 2013, the European Medicines Agency (EMA) recommended conditional marketing approval for delamanid, a medicine developed by Otsuka Pharmaceutical Japan, for use in the treatment of adult patients with MDR-TB when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.
WHO subsequently issued interim guidance in 2014, conditionally recommending that delamanid may be added to a treatment regimen in adult patients with MDR-TB, particularly those who have resistance to other key medicines of MDR-TB regimens or other risks of poor outcome. In 2016, the WHO interim guidance was expanded for use in children aged 6-17 years.
The WHO interim guidance on delamanid was based on data from Phase I and Phase II clinical trials and the results of other early studies. Use of delamaind was conditional approved by WHO given the limited alternative treatment options for MDR-TB patients, on the basis that potential benefits probably outweighed potential risks. The WHO recommendations were also conditional upon longer-term effectiveness and safety data becoming available in subsequent years, especially from Phase III randomised controlled trials.
1. European Medicines Agency - Human medicines - Deltyba.
4. WHO handbook for guideline development. 2nd ed. Geneva, World Health Organization; 2014.