Otsuka is on course to further expand use of its treatment for pulmonary multidrug resistant tuberculosis (MDR-TB) to children. Europe's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of the company's 25 mg dispersible tablet formulation of Deltyba.
Deltyba first came to market in 2014 to treat adults. The approval was extended to cover children weighing at least 30 kg last year. Both the initial approval and extension covered the same Deltyba tablet formulation, albeit with users weighing between 30 kg and 50 kg taking fewer doses. Otsuka’s plans to further lower the minimum weight rest on a different formulation.
The CHMP recommendation will allow Otsuka to provide the treatment to children weighing as little as 10 kg, the company said in a statement. The approval would cover the dispersible formulation of delamanid, the active ingredient in Deltyba. The tablet disperses in water, making it easier for younger children to swallow the medicine.
“This medicine is child-friendly and specifically developed for them,” Robert Dornheim, CEO of Otsuka Novel Products, said in a statement. "Previously, there were almost no treatment options available for this group of children.”
Standard therapies are ineffective in patients with MDR-TB, and around 30,000 children are estimated to contract the infection every year.
The CHMP recommendation is based on data from studies including a phase 2 trial that assessed the safety, tolerability and pharmacokinetics of the dispersible formulation in children with MDR-TB. The study generated evidence on the use of the formulation in children aged three to five years old that encouraged Otsuka to seek approval.