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
How Aker Security Builds Control Rooms for Real-Time Decision-Making29.1.2026 10:00:00 CET | Press release
In a new case, Aker Security demonstrates how a control room built on Cyviz’ technology platform functions as the operational nerve center for decision-making, collaboration, and preparedness. In today’s security landscape, the challenge lies in aggregating, visualizing, and using large volumes of data effectively in situations where time, precision, and coordination are critical. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260129578139/en/ GSOC Aker Security oversees security and preparedness for large parts of the Group, covering several thousand employees. Its services include travel security, global event and incident monitoring, crisis management, and security advisory services. "We approached Cyviz because we needed a solution that could bring everything together on a single platform, while at the same time supporting the way we actually work operationally," says Tonje Evensen Bråthen, Head of the Global Security Op
Multi-Color Corporation Initiates Implementation of Restructuring Agreement29.1.2026 07:58:00 CET | Press release
Commences Prepackaged Chapter 11 Process As Part of Previously Announced Restructuring Support Agreement to Reset Balance Sheet and Position Company for Long-Term Growth and InvestmentRestructuring Supported by CD&R and More Than Supermajority of Senior Secured Lenders Who Have Agreed to Backstop Nearly $890 Million Investment; Provides More Than $500 Million of New Liquidity Upon EmergenceAll Global Operations and Service to Customers Expected to Continue Without Interruption; All Trade Vendors and Suppliers Expected to be Paid in FullProvides for $250 Million of New Money Debtor-in-Possession Financing to Capitalize the Business Throughout the Prepackaged Chapter 11 Process Multi-Color Corporation (“MCC” or the “Company”), a global leader in prime label solutions, today announced that to implement the previously announced restructuring support agreement (the “RSA”), the Company has commenced its prepackaged Chapter 11 filing in the United States Bankruptcy Court for the District of N
Takeda Reports Third-Quarter FY2025 Results: Updates Full Year Outlook to Reflect VYVANSE® Generics Impact, OPEX Discipline and FX Tailwind; Progressing Toward Three Transformative Launches Ahead29.1.2026 07:37:00 CET | Press release
Year-to-Date Revenue Declined by 2.8% at Constant Exchange Rate (CER), 3.3% atActual Exchange Rates (AER);Impact of VYVANSE® Generics is Tapering OffCore Operating Profit Declined by 3.4% at both CER and AER Year to DateReported Operating Profit Increased by 1.2% at AER Year to Date, Lower Restructuring Expenses More Than Offset Impairment Takeda (TOKYO:4502/NYSE:TAK) today announced earnings results for the third quarter of fiscal year 2025 (nine months ended December 31, 2025). The gap between incremental Growth & Launch Products revenue and VYVANSE erosion is narrowing, and operational efficiencies drove year-on-year reductions in operating expenses, including R&D. The company raised its full-year forecasts based on cost discipline and FX tailwind, while its Revenue Management Guidance has been updated primarily due to the impact of VYVANSE generics. Takeda is positioned for long-term growth and has multiple late-stage programs with multibillion-dollar peak revenue potential. Follow
Galderma Unveils ‘Wake Up To Restylane’, Underscoring Restylane as the Ideal Hyaluronic Acid Treatment for Always-On Natural Beauty29.1.2026 07:00:00 CET | Press release
‘Wake Up To Restylane®’ is a global campaign designed to meet the rising demand for natural-looking always-on results, helping people wake up looking refreshed and rested, and reframes Restylane treatments from a clinical procedure into an always-on beauty regimen Backed by 30 years of science, the Restylane portfolio is the only hyaluronic acid (HA) range offering four distinct technologies, designed to deliver personalized natural-looking outcomes that provide contour, definition, and hydration, with HA closest to the skin’s own1-7 This launch builds on new clinical data presented at the International Master Course on Aging Science (IMCAS) World Congress 2026, confirming Restylane’s proven efficacy and versatility across multiple facial areas and the décolletage8-11 Galderma (SIX: GALD), the pure-play dermatology category leader, has launched ‘Wake Up To Restylane’, a global campaign that showcases Restylane as an everyday beauty ally. Aligned with the growing desire for effortless,
Ubitus Partners with Maizuru City, Kyoto to Launch AI Data Center Project, Advancing the Deployment of a Top-Tier AI GPU Center in Japan29.1.2026 07:00:00 CET | Press release
Ubitus K.K. (Headquarters: Shinjuku, Tokyo; Representative Director & CEO: Wesley Kuo), a global leader in cloud streaming and AI solutions, today announced that it will hold a land signing ceremony and press conference with Maizuru City, Kyoto Prefecture, on January 29, 2026. At the event, Ubitus will officially unveil its comprehensive plan to construct an AI Data Center in Maizuru City, marking the company’s transition into the physical construction phase of its initiative to build a top-tier AI GPU center in Japan. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260128944842/en/ Ubitus will launch its Maizuru City AI Data Center project on January 29, marking the first step toward building a top-tier AI GPU center in Japan. Powered by NVIDIA Blackwell GPUs and NeoCloud, the project strengthens Japan’s AI infrastructure and regional development. This land agreement represents the first major milestone following Ubitus’ sel
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