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• The new, pleasant-tasting treatment option is aimed at a pediatric patient population with pulmonary multi-drug-resistant tuberculosis (MDR-TB)

• For use in patients for whom no other effective treatment regimen is available

• Every year between 25,000 and 32,000 children worldwide develop MDR-TB

As announced today by Otsuka Novel Products GmbH (ONPG), a subsidiary of Otsuka Pharmaceutical Co., Ltd., the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has received approval of Deltyba 25 mg film-coated tablets (Delamanid) recommended for use as part of a suitable combination regimen for pulmonary MDR-TB in adults, adolescents, children and infants weighing at least 10 kg, unless an effective treatment regimen is available due to resistance or insufficient tolerance.

According to the latest Global TB Report by the World Health Organization, 1.2 million children (0-14 years of age) developed TB in 2019.

According to a scientific publication, around 25,000 to 32,000 children worldwide develop MDR-TB every year. Few of these children will be diagnosed and successfully treated, and about 21% of children with MDR-TB are likely to die from it.

The new global goals defined at the 2018 UN high-level meeting on TB include treating 115,000 children with drug-resistant TB over the five-year period from 2018 to 2022.

"Otsuka has committed itself to the goal of meeting urgent medical needs - especially in the case of particularly vulnerable and underserved population groups such as children with MDR-TB," said Robert Dornheim, CEO at Otsuka Novel Products GmbH. “This drug is good for children and has been specially developed for them. So far, there have been virtually no treatment options for children with this condition.

The approval is based on the results of two clinical studies (Phase 1 and 2) examining the pharmacokinetics, safety and efficacy of the new formulation in pediatric patients from birth to 17 years of age. The safety and tolerability data from both pediatric studies were consistent with the previously known safety and tolerability profile of delamanid in the adult population.

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