OTSUKA
26.7.2021 12:02:09 CEST | Business Wire | Press release
Otsuka Novel Products GmbH (ONPG), a subsidiary of Otsuka Pharmaceutical Co., Ltd., is pleased to announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) 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.
The current World Health Organization Global TB Report estimates that 1.2 million children (0-14 years of age) fell ill with TB in 2019.2
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.1
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. 3
“Otsuka’s mission is to address unmet medical needs – particularly for the most vulnerable and underserved populations such as children with MDR-TB,” says Robert Dornheim, CEO of Otsuka Novel Products GmbH. “This medicine is child-friendly and specifically developed for them. Previously, there were almost no treatment options available for this group of children.”
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. 4,5
######
About Deltyba (delamanid)
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.7 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).8-10
About MDR/RR-TB
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.2 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.2 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.11,12
About Otsuka Novel Products GmbH
Otsuka Novel Products GmbH (ONPG), based in Munich, Germany, is dedicated to finding innovative solutions to fight the global pandemic of tuberculosis (TB). 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.
ONPG is a part of Otsuka Pharmaceutical Company, Ltd., a subsidiary of Otsuka Holdings Co., Ltd. headquartered in Tokyo, Japan. Otsuka Pharmaceutical is a global healthcare company with the corporate philosophy: “Otsuka-people creating new products for better health worldwide.”
Otsuka researches, develops, manufactures and markets innovative products, with a focus on pharmaceutical products to meet unmet medical needs and nutraceutical products for the maintenance of everyday health. Further information is available at www.otsuka-onpg.com .
###
Sources:
1
Jenkins H, et al
. The burden of multidrug-resistant tuberculosis in children. Int J Tuberc Lung Dis
. 2018; 22: 3-6.
2
World Health Organisation. Global TB Report 2020. Available at: https://www.who.int/teams/global-tuberculosis-programme/tb-reports/global-tuberculosis-report-2020
(Last accessed July 2021)
3
UN 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 July 2021)
4
EudraCT. Phase 1, open-label, multiple-dose, and age de-escalation trial to assess the pharmacokinetics, safety, and tolerability of delamanid (OPC-67683) in paediatric multidrug-resistant tuberculosis patients on therapy with an optimized background regimen of anti-tuberculosis drugs. Available at: https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-004473-25/results
(Last accessed July 2021)
5
EudraCT. Phase 2, open-label, multiple-dose trial to assess the safety, tolerability, pharmacokinetics, and efficacy of delamanid (OPC-67683) in paediatric multidrug-resistant tuberculosis patients on therapy with an optimized background regimen of anti-tuberculosis drugs over a 6-month treatment period. Available at: https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-004620-38/results
(Last accessed July 2021)
6
Matsumoto M, et al
. OPC-67683, a nitro-dihydro-imidazooxazole derivative with promising action against tuberculosis in vitro and in mice. PLoS Med
. 2006; 3(11): e466.
7
Deltyba (delamanid) EU Summary of Product Characteristics (April 2021). Available at: https://www.ema.europa.eu/en/documents/product-information/deltyba-epar-product-information_en.pdf
(Last accessed July 2021)
8
Gler M, et al.
Delamanid for multidrug-resistant pulmonary tuberculosis. N Engl J Med.
2012; 366: 2151-2160.
9
Skripconoka V, et al.
Delamanid improves outcomes and reduces mortality in multidrug-resistant tuberculosis. Eur Respir J
. 2013; 41:1393-400.
10
von Groote-Bidlingmaier F, et al.
Efficacy and safety of delamanid in combination with an optimised background regimen for treatment of multidrug-resistant tuberculosis: a multicentre, randomised, double-blind, placebo-controlled, parallel group phase 3 trial. Lancet Respir Med.
2019; 7: 249-259.
11
Access to Medicine Foundation. Ending the burden of HIV, malaria and TB in children. June 2020. Available at: https://accesstomedicinefoundation.org/media/uploads/downloads/5ee1fd19b7187_ATMF_Ending_the_Big3_on%20Children-Full_09June20.pdf
(Last accessed July 2021)
12
Ignatius E, et al
. New drugs for the treatment of tuberculosis. Clin Chest Med
. 2019; 40: 811-827.
Date of preparation: July 2021
OND-DEL-2100001
View source version on businesswire.com: https://www.businesswire.com/news/home/20210726005331/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Hitachi Announces Strategic Partnership With Anthropic to Strengthen "Lumada 3.0" Through Frontier AI19.5.2026 02:00:00 CEST | Press release
Combining Hitachi’s 110+ years of domain expertise with frontier AI will advance safe real-world deployment of physical AI and strengthen customer AI transformation Deploying advanced AI across all business processes for approximately 290,000 employees to enhance productivity at scale Developing 100,000 AI professional talent and co-creating new HMAX solutions leveraging proven outcomes from Hitachi’s “Customer Zero” approach Establishing the “Frontier AI Deployment Center,” a global organization spanning North America, Europe, and Asia with an initial team of 100 experts Hitachi, Ltd. (TSE:6501, "Hitachi") today announced a strategic partnership with Anthropic PBC (“Anthropic”), a global leader in AI safety research and trusted AI models, to further strengthen the “Lumada 3.0” business model. As artificial intelligence evolves beyond cyberspace to directly influence real-world systems—otherwise known as physical AI—demand is rapidly growing for the safe and seamless deployment of AI i
Moore Nanotechnology Systems (Nanotech) Will Be Acquired by Shibaura Machine Group to Form a New Ultra-Precision Machine Tool Organization18.5.2026 21:36:00 CEST | Press release
MOORE NANOTECHNOLOGY SYSTEMS (“Nanotech”), today announced that it is being acquired by an affiliate of SHIBAURA MACHINE CO., LTD., an industrial machine-tool manufacturer headquartered in Japan. Founded nearly 30 years ago by Len Chaloux and Newman Marsilius III as a standalone subsidiary of the Moore Tool Company, Inc., Nanotech has become a global leader in the design, development and manufacture of state-of-the-art ultra-precision machine tools and associated processes for the production of advanced optical and reflective components. “As the world’s markets continue to develop, finding the right strategic partnerships is essential,” said Mark Boomgarden, President and CEO of Nanotech. “Partnering with Shibaura allows us to combine the true competencies of both organizations under one management team - affording both companies the ability to scale resources and invest on a global stage like never before.” Co-owner Newman Marsilius IV shared, “Moore Nanotechnology Systems grew to a p
First Guests Arrive at Four Seasons Resort and Residences Red Sea at Shura Island from 20 May, as Red Sea Global Launches First JV Resort18.5.2026 20:06:00 CEST | Press release
RSG and Kingdom Holding Company bring first joint venture-developed resort at The Red Sea to market Red Sea Global (RSG), the regenerative tourism developer, has reached a major milestone as Four Seasons Resort and Residences Red Sea at Shura Island welcomes first guests from 20 May, marking the first joint venture-developed resort within its portfolio to enter the market. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260518349628/en/ An aerial view of Four Seasons Resort and Residences at Shura Island, set along the shoreline with clear views of the Red Sea. Developed in partnership with Kingdom Holding Company (KHC), the launch represents a shared milestone for both organizations and marks a new phase in RSG’s development model, highlighting the growing role of institutional and private sector partnerships in scaling Saudi Arabia’s luxury tourism sector. “With Four Seasons preparing to welcome guests, we are significantly
Belkin Advances Towards Carbon Neutrality in Scope 3 Emissions18.5.2026 18:10:00 CEST | Press release
The company’s 2025 Impact Report highlights its continued progress in emissions reduction, circular design, and responsible packaging Belkin, a leading consumer electronics brand for 40 years, published its 2025 Impact Report, highlighting key achievements and reaffirming its commitment to corporate responsibility. Having achieved carbon neutrality in scope 1 and scope 2 emissions in 2025, the company continues to advance toward scope 3 carbon neutrality through enhanced life cycle assessment capabilities and improved supplier and logistics data collection. In 2025, Belkin calculated 131 product carbon footprints across its portfolio, surpassed 21.6 million PCR products sold, and has achieved a 95% reduction in single-use plastic packaging since 2019, reflecting continued progress in carbon reduction and responsible product design. “As we continue to make progress against our sustainability goals, we are taking deliberate steps to reduce our impact,” said Steven Malony, CEO of Belkin.
Infobip Named a Leader in the 2026 Gartner® Magic Quadrant™ for Communications Platform as a Service18.5.2026 16:25:00 CEST | Press release
Recognized for Completeness of Vision and Ability to Execute Infobip is excited to share that global AI-first cloud communications platform Infobip has been recognized as a Leader in the 2026 Gartner Magic Quadrant for Communications Platform as a Service. Check back for a complimentary copy of the full report soon! In Infobip’s view, this recognition reflects what the company has spent 20 years building: a communications platform that stays focused on what customers actually need and evolves as markets change. Infobip believes that recognition in a fast-moving market comes not from chasing trends, but from disciplined execution and a clear long-term vision. As Infobip marks its 20th year of operations, the company thinks the shift to agentic AI represents the most significant transformation in customer communications in our history. Infobip believes enterprises need a partner that empowers them to move from campaigns and rigid workflows to autonomous, goal-driven interactions, while r
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom