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
Global Beauty Market Grows 10% as AI and E-commerce Reshape Consumer Buying1.4.2026 03:00:00 CEST | Press release
Online sales outpace in-store by 6x as digital-first and AI-influenced commerce accelerates globally NielsenIQ (NYSE:NIQ), a global leader in consumer intelligence, today released its State of Beauty 2026 report, showing the global beauty market grew 10% year-on-year, with E-commerce expanding six times faster than in-store sales. The findings highlight a rapid shift to digital-first, AI-influenced commerce across key global markets. As consumer expectations evolve toward convenience, personalization, and seamless digital experiences, beauty brands are under increasing pressure to adapt. From AI-powered product discovery to social commerce and livestream shopping, the path to purchase is becoming more dynamic—requiring brands to move faster and engage consumers across an increasingly complex ecosystem. Key findings from the State of Beauty 2026 report: Global beauty sales grew 10% year-over-year, driven by strong digital acceleration E-commerce is growing 6x faster than in-store sales,
bet365 Partners with TestMu AI to Accelerate Global Release Velocity with Agentic AI Quality Engineering31.3.2026 19:01:00 CEST | Press release
Streamlines Hillside Technology testing across browsers and mobile devices while supporting rapid expansion into regulated markets. TestMu AI (Formerly LambdaTest), the world's first full-stack Agentic AI Quality Engineering platform, today announced that Hillside Technology Limited, the technology powerhouse behind global online gambling leader bet365, has adopted its platform to unify software testing and support hundreds of weekly production releases. The global online gaming industry is currently experiencing a massive shift, with the market projected to exceed $150 billion by 2030. As mobile gaming becomes the primary touchpoint for users, the technical complexity of delivering a seamless, low-latency experience has grown exponentially. For industry giants like bet365, the need to validate software across an infinite matrix of hardware, screen resolutions, and OS versions is a mission-critical requirement. This partnership ensures that, as gaming becomes more mobile-centric, bet36
IFF Secures First Heart Health Claim for Soy Protein in Australia and New Zealand31.3.2026 16:00:00 CEST | Press release
Regulatory milestone opens heart health growth opportunities for food and beverage manufacturers IFF (NYSE: IFF), a global leader in flavors, fragrances, food ingredients and health & biosciences announced today that a new heart health claim for isolated soy protein has been accepted by the Food Standards Australia New Zealand (FSANZ). The approval enables food and beverage manufacturers in Australia and New Zealand to link soy protein consumption with healthy blood cholesterol levels. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260330523416/en/ First heart health claim approved for soy protein in Australia and New Zealand. “For decades, IFF has invested in the science behind soy protein and its role in supporting cardiovascular health,” said Tony Andrew, vice president of protein solutions for IFF Food Ingredients. “This approved claim validates years of rigorous research and collaboration. With our deep expertise in ing
Sub-Q Bionics Closes $1.5M Pre-Seed Round to Advance Next-Generation Solution for Lymphedema Care31.3.2026 15:26:00 CEST | Press release
Sub-Q Bionics, a medical device company developing next-generation solutions to improve care for patients living with lymphedema, today announced the successful close of its $1.5 million pre-seed funding round. The round includes investment from Mayo Clinic and Yeda, the technology transfer company of the Weizmann Institute of Science, as well as several private investors. The Israel Innovation Authority also provided matching funds. The funding will enable Sub-Q Bionics to continue to develop its novel bionic lymph node technology designed to transform how lymphedema is managed, based on scientific innovations from the Weizmann Institute and Shamir Medical Center. The system aims to provide a solution to manage fluid with a subcutaneous implant that will allow patients freedom of movement, automatic fluid management and reduction of symptoms such as pain and swelling. Lymphedema affects millions of patients worldwide, especially breast cancer survivors, and remains significantly under
HTEC Achieves SOC 2 Type II Attestation, Reinforcing Commitment to Client Trust31.3.2026 15:25:00 CEST | Press release
HTECtoday announced that it has successfully achieved a SOC 2 Type II attestation, audited by Deloitte, demonstrating the company’s commitment to maintaining high standards in security, availability, and confidentiality. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260331132225/en/ HTEC today announced that it has successfully achieved a SOC 2 Type II attestation, audited by Deloitte, demonstrating the company’s commitment to maintaining high standards in security, availability, and confidentiality. For clients, this means working with a technology partner whose practices are standardized, consistently executed, and independently verified over time. It reflects a level of operational maturity where security, reliability, and data protection are built into every engagement. Achieving this standard required coordinated effort across the entire organization. Compliance, engineering, delivery, security, IT, legal, and people t
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