Otsuka Pharmaceutical Co says that enrollment has begun for "a ground-breaking clinical programme" looking at its investigational drug delamanid for paediatric multidrug-resistant tuberculosis (MDR-TB).
The Japanese firm notes that it is the first company to perform a trial among this population, adding that the programme will also evaluate the bioequivalence of a dispersible formulation for use with younger children and infants. Otsuka says that "childhood TB is a neglected segment of an already neglected disease" and the World Health Organisation estimates that there are 500,000 cases resulting in 64,000 deaths worldwide.
A recommendation on the use of delamanid in adult MDR-TB patients is expected later this month from the European Medicines Agency's Committee for Medicinal Products for Human Use. The compound is also under regulatory review in Japan.