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  5. Otsuka Announces Approval in EU of Pediatric, 25 mg Dispersible-Tablet Formulation of Deltyba™ for Multidrug-Resistant Tuberculosis

October 6, 2021

Otsuka Pharmaceutical Co., Ltd.

Pharmaceuticals

Otsuka Announces Approval in EU of Pediatric, 25 mg Dispersible-Tablet Formulation of Deltyba™ for Multidrug-Resistant Tuberculosis

Otsuka Pharmaceutical Co., Ltd. (Otsuka Pharmaceutical) is pleased to announce that Otsuka Novel Products GmbH, a Germany based subsidiary of Otsuka Pharmaceutical, has obtained regulatory approval from the European Commission for the Deltyba™ (delamanid) 25-mg dispersible tablet formulation. This formulation of Deltyba is for use as part of a drug treatment regimen, when an effective treatment regimen cannot otherwise be composed, for children weighing at least 10 kg who have pulmonary multidrug-resistant tuberculosis (MDR-TB).

The Global Tuberculosis Report 2020 produced by the World Health Organization notes that 1.2 million children (ages 0 to14) suffered from tuberculosis (TB) in 2019.*1 Also, according to a paper published in The International Journal of Tuberculosis and Lung Disease, between 25,000 and 32,000 children worldwide develop MDR-TB each year, and it is likely that around 22 percent of children developing MDR-TB will die.*2 One of the new global goals that was set at the United Nations General Assembly High-Level Meeting on TB in 2018 was to treat 115,000 children with drug-resistant TB over a five-year period.*3

Masanori Kawasaki, Global TB Project leader at Otsuka Pharmaceutical, said, "Otsuka Pharmaceutical has been conducting TB research and development for many years with the aims to deliver therapeutic drugs to as many patients as possible and ultimately eradicate TB around the world. We hope that the newly approved dosage form of Deltyba will contribute to the treatment of MDR-TB in children. We will continue to pursue the SDG goals, especially Good Health and Well-Being (goal #3), through the development of anti-TB drugs."

About delamanid

Delamanid (brand name is Deltyba) is a compound created by Otsuka Pharmaceutical with a new mechanism of action with anti-TB activity that occurs through inhibition of the synthesis of mycolic acid, an essential component of mycobacterial cell wall.
Currently, delamanid is approved in Europe, Japan, South Korea, China, India, South Africa, Russia and other countries. It was added to the WHO Model List of Essential Medicines in 2015 and to date has been used to treat patients with MDR-TB in more than 110 countries. Last year in Europe, approval was granted for Deltyba 50 mg film-coated tablets to be used in children and adolescents weighing at least 30 kg.

  1. 1World Health Organisation. Global Tuberculosis Report 2020. Available at: https://www.who.int/teams/global-tuberculosis-programme/tb-reports/global-tuberculosis-report-2020 (Last accessed Sept. 2021)
  2. 2Jenkins H, et al. The burden of multidrug-resistant tuberculosis in children. Int J Tuberc Lung Dis. 2018; 22: 3-6.
  3. 3UN High Level Meeting on TB 2018 - Key Targets and Commitments. Available at:
    http://www.stoptb.org/assets/documents/global/advocacy/unhlm/UNHLM_Targets&Commitments.pdf (Last accessed Sept. 2021)

Information in this news release was current as of the original release date.

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