OTSUKA
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
Enerin raises €15 million Series A to industrialise modular high-temperature heat pumps for global industry26.11.2025 10:00:00 CET | Press release
Norway-based technology leader in industrial heat pumps, Enerin AS, has raised €15 million in an oversubscribed Series A led by Climentum Capital, The Footprint Firm, Johnson Controls and Move Energy. The investment marks Enerin’s transition from technology pioneer to serial production. Proceeds will expand commercial and manufacturing operations, and accelerate next-generation development. Johnson Controls’ participation provides strategic validation and global reach from one of the world’s leading providers of energy systems. Enerin, a technology leader in high-temperature heat pumps, has raised €15 million (NOK 180 million) in a Series A led by Climentum Capital, The Footprint Firm, Johnson Controls and Move Energy, with participation from PSV Hafnium and Momentum. “This investment marks our shift from pioneering to full industrialisation, bringing proven high-temperature technology from Norway to industries worldwide,” said Arne Høeg, Founder and CEO of Enerin. “Industrial companie
IQM to Invest Over €40 Million to Expand Finland Production Facility, Accelerate Innovation and Fuel Growth26.11.2025 09:49:00 CET | Press release
The new facility will produce advanced quantum chips for error corrected quantum computers, almost double the cleanroom space and system assembly line capacity to produce up to 30 quantum computers per year. The integrated quantum computer production line will be one of the world’s most advanced of its kind combining fabrication of quantum chips and system assembly. The expansion is expected to be completed by the first quarter of 2026. The expansion is part of IQM’s long-term commitment to scale its infrastructure and execute the ambitious technology roadmap aiming at 1M quantum computers by 2033. IQM Quantum Computers, a global leader in superconducting quantum computers, today announced over €40 million investment to expand its state-of-the-art production facility in Finland. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251126943986/en/ This strategic expansion will accelerate the development, fabrication and testing of
Thredd Powers Successful Migration of BigPay’s Card Portfolio to Next-Gen Platform26.11.2025 09:00:00 CET | Press release
The transition of millions of cards showcases Thredd’s superior capabilities amid a high-stakes, global trend of sunsetting legacy processing engagements Thredd, the leading next-generation global payments processor, has successfully migrated BigPay’s virtual and physical card portfolio from its previous, legacy processor to Thredd’s next-generation platform, underscoring Thredd’s leadership in complex card portfolio migrations. The migration project, one of several in recent years, included over 2.5 million cards and highlights Thredd’s unique combination of deep migration experience, robust processes, and advanced technology—qualities increasingly critical as the industry faces a wave of modernisation and replatforming. This achievement comes at a pivotal moment for the industry. Industry analysts estimate that retail banks failing to modernise could see 10% to 15% of their payments revenue at risk annually as legacy platforms struggle to keep pace with demands for hyperpersonalizati
With Two in Five Employees Undergoing Fertility Treatment Leaving Their Jobs or Considering Quitting, Are Companies Doing Enough?26.11.2025 08:00:00 CET | Press release
An international survey, spanning Australia, France, Japan, Poland and the UK, has found that many employees experiencing fertility challenges lack support in the workplace, with almost two in five (39%) leaving or considering leaving their roles while undergoing treatment.1 ‘The Impact of Fertility Challenges at Work: International Insights’ survey by Ferring Pharmaceuticals, Fertility Matters at Work and This Can Happen shows that, despite growing awareness of reproductive health, two thirds (67%) who have experienced fertility challenges say that their workplaces do not offer support for employees undergoing fertility treatment, with France the least likely to provide it (88%).1 60% said they were not clearly entitled to time off for fertility appointments, with time recorded as paid leave, unpaid leave or annual leave (26%), and some also reported taking sick leave due to a lack of flexibility (17%).1 With assisted reproduction therapy, including IVF, already accounting for up to 1
Venture Global and Tokyo Gas Announce 20-Year LNG Sales and Purchase Agreement26.11.2025 01:00:00 CET | Press release
Venture Global’s fourth long-term contract with a Japanese company7.75 MTPA of long-term contracts signed by Venture Global to date in 2025 Today, Venture Global, Inc. (NYSE: VG) and Tokyo Gas Co., Ltd announced the execution of a new, long-term liquefied natural gas (LNG) Sales and Purchase Agreement (SPA). Under the SPA, Tokyo Gas will procure 1 million tonnes per annum (MTPA) of LNG from Venture Global for 20 years, starting in 2030. This deal marks 7.75MTPA of SPAs signed by Venture Global in the last six months. “With nearly 8 MTPA of new long-term commitments signed this year, Venture Global is pleased to build on our commercial momentum through this new partnership with Tokyo Gas,” said Venture Global CEO Mike Sabel. “Tokyo Gas is a pioneer in the LNG industry and leading provider of natural gas to Japan, and we look forward to working with them as we grow our position as a top LNG supplier to Japan. This agreement will contribute significantly to the US-Japan balance of trade o
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