Enrollment has begun for a ground-breaking clinical program exploring the use of delamanid in paediatric multidrug-resistant tuberculosis (MDR-TB). Otsuka is the first company to perform a trial among this population for regulatory approval. The programme will also evaluate the bioequivalence of a dispersible formulation for use with younger children and infants.
Childhood TB is a neglected segment of an already neglected disease. The WHO estimates that there are a half-million cases of childhood TB resulting in 64,000 deaths worldwide. In a recent report, the European Medicines Agency highlighted the success of paediatric regulation in spurring high-quality research, better information on the use of medicine in children and more age-appropriate formulations (www.ema.europa.eu/docs/en_GB/document_library/Other/2013/06/WC500143984.pdf).
A recommendation on the use of delamanid in adult MDR-TB patients is expected later this month from the European Committee for Medicinal Products for Human Use. The compound is also under regulatory review in Japan and a Phase 3 trial in adult MDR-TB patients is already underway, including those with co-existing HIV infection.
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For more information on delamanid go to http://www.newtbdrugs.org/project.php?id=136.