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
Vena Completes Acterys Acquisition to Accelerate Orchestrated Planning for the Microsoft Ecosystem26.3.2026 14:00:00 CET | Press release
The combination connects AI-driven financial and operational planning, analytics and execution across Microsoft Excel and Power BI, removing decision latency for Microsoft-centric enterprises. Vena, the AI-powered Orchestrated Performance Management platform purpose-built to fully amplify the Microsoft technology ecosystem, today announced it has completed its acquisition of Acterys, the leading Microsoft Power BI–based operational planning and app development platform. The move strengthens Vena’s Orchestrated Planning solution and begins phased integration of the two platforms. Modern enterprises are struggling to keep up with the volatility and dynamism of the markets they serve. Market drivers and signals shift rapidly, and the ability to assess, plan and execute with confidence and speed is more important than ever. These forces, combined with overwhelming data density and disparity, have created a new constraint: decision latency—the time between signal and action. As that gap wid
Nearly Half of Global C-Suites Plan U.S. Expansion Within 12 Months, as Supply Chain and Capital Access Drive Growth26.3.2026 14:00:00 CET | Press release
• 45% of C-level executives plan to establish a U.S. legal entity within the next 12 months; a further 27% say they will consider entry within two to three years • 65% cite supply chain or manufacturing efficiency as the primary driver for U.S. expansion • 88% identify federal and state tax reporting as the most burdensome area of U.S. compliance Nearly half (45%) of global C-suite leaders plan to establish a legal entity in the United States within the next 12 months, highlighting continued demand for access to the U.S. market. This finding from the latest research by CSC—the leading provider of global business administration and compliance solutions—demonstrates the U.S. continues to attract investment from around the world, even as companies face an increasingly complex regulatory landscape. CSC surveyed 300 C-level executives at large organizations headquartered in Europe, the U.K., Asia Pacific, and South America to examine global sentiment toward U.S. market entry, including expa
Lone Star Funds Completes Acquisition of Alliance Ground International26.3.2026 13:30:00 CET | Press release
Lone Star Funds (“Lone Star”) today announced that an affiliate of Lone Star Fund XII, L.P. has completed the acquisition of Alliance Ground International (“AGI”), a leading North American airport services provider. “We are excited to partner with the AGI management team to drive the business forward,” said Donald Quintin, Chief Executive Officer of Lone Star. “The company has a superior service offering and a track record of success across its integrated operations. We see opportunities to continue to invest in the business and its people to continue to grow its capabilities and ensure it remains best-in-class in delivering for the aviation industry.” “Today marks an important next step for AGI as we move forward in partnership with Lone Star,” said Jared Azcuy, Chief Executive Officer of AGI. “Our commitment to safety, reliability, and operational service excellence remains unchanged. This partnership strengthens our ability to deliver for our airline partners and reinforces that the
Rubedo Life Sciences Announces Positive Preliminary Phase 1 Clinical Trial Results for Lead Drug Candidate RLS-1496 in Patients with Plaque Psoriasis, Atopic Dermatitis, and Skin Aging26.3.2026 13:30:00 CET | Press release
The Phase 1 study of RLS-1496, the first human trial of a GPX4 (selective glutathione peroxidase 4) modulator, met its primary endpoint and also demonstrated a statistically significant relationship between target engagement and clinical improvement in psoriasis and atopic dermatitis RLS-1496 is a first-in-class disease-modifying mechanism targeting pathological senescent cells that drive inflammaging and chronic degenerative diseases of aging A second study for RLS-1496 – a Phase 1b/2a study in actinic keratosis (precancerous skin lesions) – is underway in the United States, with completion expected later this year Rubedo CEO Frederick Beddingfield, III, MD, PhD, FAAD, to moderate panel on senescence and skin at the Dermatology Innovation Forum (DIF) during the American Academy of Dermatology (AAD) annual meeting on Thursday, March 26, at 1:05 pm MT in Denver Oral presentation of data accepted at the Society for Investigative Dermatology (SID) from May 13-16, 2026, in Chicago Rubedo L
GE HealthCare announces lead industrial role in largest EU-funded IHI consortium to advance cardio-oncology care across Europe26.3.2026 13:30:00 CET | Press release
COMPASS is one of the largest public‑private partnerships under the European Union’s (EU) Innovative Health Initiative (IHI). The consortium aims to advance early detection and prediction of cardiotoxicity in cancer patients and cancer survivors. The initiative will leverage AI, advanced imaging, biomarkers, and integrated care pathways. GE HealthCare (Nasdaq: GEHC) today announced its leading industrial role in the new COMPASS consortium, a five-year initiative focused on improving precision cardio-oncology care and advancing early detection of cardiovascular risks in cancer patients across Europe. COMPASS combines clinical excellence with novel healthcare technology, and with a total budget of €50.5 million and more than sixty partners, it is one of the largest public-private partnerships under the IHI. Cardiovascular diseases are rising sharply among cancer patients and survivors, driven both by the increasing prevalence of pre‑existing cardiovascular conditions at diagnosis and by
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