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
Cyviz Launches Unified Software Platform to Support Complex Environments8.4.2026 11:00:00 CEST | Press release
Cyviz AS announces the launch of its enhanced software platform, marking a milestone in the company’s strategic transition toward becoming a technology‑ and platform‑led company. The Cyviz Software Platform helps organizations monitor, manage, and optimize complex AV and IoT environments through a single, unified software layer. Across industries such as energy, defense, transportation, consulting, and large enterprise environments, organizations increasingly rely on complex, multivendor technology ecosystems to support critical operations. These are often managed using fragmented tools, resulting in limited visibility, higher operational risk, and reactive maintenance. Cyviz’ platform addresses this challenge by unifying monitoring and management across technologies, vendors, and locations. With real-time insights, proactive alerts, and centralized control, organizations can move from reactive incident handling to more predictable and resilient operations. “Many organizations are stru
Reply Selected by Microsoft as Launch Partner for Agent 365, Supporting the Governance and Scaling of AI agents8.4.2026 10:17:00 CEST | Press release
Reply [EXM, STAR: REY] has been confirmed one of a small number of Launch Partners for Agent 365, supporting the general availability of Microsoft's new platform designed to provide enterprise-grade governance, observability and lifecycle management for AI agents. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260408212380/en/ Through this collaboration with Microsoft, Reply reinforces its commitment to enabling organisations to implement artificial intelligence responsibly and at scale, supporting long-term digital transformation objectives. Microsoft Agent 365 introduces a structured framework enabling organisations to deploy, monitor and manage AI agents consistently across business functions. As artificial intelligence becomes embedded in core operational processes, Agent 365 provides clarity, control and accountability, ensuring that AI-driven activities remain transparent, secure and aligned with organisational objecti
HPE Takes Licence to Patents Offered Through the Sisvel Wi-Fi Multimode Pool8.4.2026 10:00:00 CEST | Press release
Hewlett Packard Enterprise (HPE) has become the latest company to take a licence to the patents offered through the recently launched Sisvel Wi-Fi Multimode pool. It joins Sony Group Corporation, Huawei, Panasonic, Philips and ZTE as a licensee of the programme. The latter four are also licensors, along with KPN, Mitsubishi Electric, Orange, Aegis 11 SA (a Sisvel affiliate), SK Telecom and Wilus. HPE is a major presence in the global WLAN market and is a leading manufacturer of both consumer and enterprise routers. The deal with Sisvel was reached on an amicable basis. The Sisvel Wi-Fi Multimode pool is the successor programme to the Sisvel Wi-Fi 6 patent pool. Over a three-year period, this closed agreements with nearly 40 companies, including Acer, Netgear, Cisco and HP. Covering Wi-Fi 7 as well as 6, the Multimode programme offers an efficient way to access essential Wi-Fi rights for years to come. “We are delighted to welcome Hewlett Packard Enterprise as the latest licensee of the
Zyxel and Openreach Team Up to Reduce Plastic Waste in Full Fibre Installations8.4.2026 10:00:00 CEST | Press release
A new partnership between Zyxel Communications and Openreach is helping to cut plastic and packaging waste from the UK’s Full Fibre rollout - by deploying re-cycled ‘modems’ to connect customers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260408766604/en/ Openreach - GPON ONT Zyxel is deploying a range of new Optical Network Terminals (ONTs) - the wall-mounted box of electronics that converts optical signals into electrical ones used by household devices - with re-engineered casings made from 95 per cent recycled plastic.1 Openreach engineers have already installed half a million of Zyxel’s sustainable ONTs and the network provider expects to install even more this year as customers upgrade to Full Fibre - the UK’s most reliable broadband technology. The GPON2 devices use recycled plastic in their construction and arrive in zero‑plastic minimal packaging made from recycled materials. Openreach is working with Zyxel and o
Jeito Capital Hits Record $1.2 Billion (€1 Billion)1 Close for Jeito II Fund to Drive Breakthrough Therapeutic Innovation for Patients8.4.2026 08:15:00 CEST | Press release
This record closing is the largest raise ever achieved by a fully independent European fund dedicated to Biopharma, validating Jeito’s patient-driven investment strategy, its multidisciplinary, collaborative expertise spanning from science to commercialization of medicines, and value creationIn five years, Jeito Capital has tripled its assets under management to €1.6 billion, firmly establishing itself among the top-tier global Biopharma investorsJeito II will build on Jeito I’s proven and differentiated strategy, investing in the most promising clinical Biopharma companies which address unmet patient needs and severe diseases, accelerate breakthrough therapeutic innovation, and deliver transformative benefits for patientsThis fundraise represents significant momentum for European Biopharma, strengthening its financial firepower and expertise to develop the next generation of global champions Jeito Capital (“Jeito”), a global independent private equity fund dedicated to Biopharma, toda
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