Policy & Regulation
CHMP grants positive opinion in the European Union for Otsuka's child-friendly 25 mg dispersible tablet formulation of Deltyba for the paediatric population weighing at least 10 kg with pulmonary multi-drug resistant tuberculosis
27 July 2021 - - The Committee for Medicinal Products for Human Use of the European Medicines Agency recommends approval of Deltyba 25 mg dispersible tablets (delamanid) for use as part of an appropriate combination regimen for pulmonary MDR-TB in adults, adolescents, children and infants with a body weight of at least 10 kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability, Japanese pharmaceutical company Otsuka Pharmaceutical Co., Ltd's Germany-based Otsuka Novel Products GmbH subsidiary said.

The current World Health Organization Global TB Report estimates that 1.2m children (0-14 years of age) fell ill with TB in 2019.

According to a scientific publication, every year approximately 25,000-32,000 children world-wide fall ill with MDR-TB. Of these, only a few are diagnosed and treated successfully and approximately 21% of children with MDR-TB are likely to die.

New global targets set at the UN's High Level Meeting on TB in 2018 include treating 115,000 children with drug-resistant TB in the five-year period 2018-2022. 

The approval is based on the results of two clinical trials (Phases 1 and 2) evaluating the pharmacokinetics, safety and efficacy of the new formulation in paediatric patients ranging from birth to 17 years of age.

Safety and tolerability data from the two paediatric trials were in line with the known safety and tolerability profile of delamanid in the adult population, the company said.

Deltyba (delamanid) inhibits the synthesis of mycolic acid, an essential component of mycobacterial cell walls.6 It has been in use since 2014 as part of an appropriate combination regimen for pulmonary MDR-TB in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.

Delamanid has already exhibited anti-TB efficacy and a favourable safety and tolerability profile in multiple Otsuka-sponsored clinical trials in adult patients, including two Phase 2 studies, an open-label registry (Trials 204/208/116), and one Phase 3 study (Trial 213).

In 2019, an estimated 465,000 people acquired rifampicin-resistant TB (RR-TB), and of these, 78% had MDR-TB, a type of TB resistant to both rifampicin and isoniazid.

TB is one of the most serious infectious diseases and drug-resistant TB is considered a global public health emergency by the World Health Organization.

New treatment options for such patients are urgently needed. At the same time, it needs to be ensured that TB drugs remain effective for as long as possible, especially since there have only been a few new medications developed to treat drug-resistant forms of TB in the last 50 years.

Otsuka Novel Products GmbH, based in Munich, Germany, is dedicated to finding innovative solutions to fight the global pandemic of tuberculosis.

As the marketing authorization holder for Deltyba (delamanid) in the European Union, ONPG works in collaboration with the Otsuka group of companies, non-governmental organisations and other stakeholders, to expand access to Deltyba (delamanid) and fight MDR-TB.