EMA develops new guidance on drug-resistant TB treatments

Published: 11-Dec-2014

Suggests updating a section on rational dose selection for new agents and regimens


The European Medicines Agency (EMA) has suggested changes to guidance for pharmaceutical companies developing medicines treating multi-drug resistant tuberculosis.

A discussion paper has been released that says advice should better address clinical study designs evaluating the efficacy of new treatments. It suggests updating a section on rational dose selection for new agents and regimens, 'including models that can take into account the effects of growth phases and intracellular accumulation'.

EMA also wants an update to assessing the predictive value of various biomarkers indicating cures.

Other proposed changes would focus on discussing the number and duration of studies required for post-treatment follow-ups before filing a market approval application, and on the use of rapid diagnostic tests to detect tuberculosis and resistance mechanisms.

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