OTSUKA
21.9.2020 13:14:10 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 extension of the indication for Deltyba® (delamanid) for children. This means Deltyba® (delamanid) is recommended by the CHMP for use as part of an appropriate combination regimen for pulmonary MDR-TB in adults, adolescents and children with a body weight of at least 30kg when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability.
According to the current World Health Organization Global TB Report, an estimated 1.1 million children (0-14 years of age) fell ill with TB in 2018.2 Each year, approximately 25,000-32,000 children fall ill with MDR-TB. Of these, only 3-4% are diagnosed and treated and consequently, approximately 21% of children with MDR-TB are likely to die.1
New global targets set at the UNs High Level Meeting on TB two years ago include treating 115,000 children with drug-resistant TB in the five-year period 2018-2022.2
“This positive CHMP opinion is a further milestone in Otsuka’s mission 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. “We look forward to working with the TB community to further enhance access of delamanid in this age group.”
The positive opinion for the label extension is based on data accumulated from the first two paediatric patient groups enrolled in delamanid paediatric trials: Study 242-12-232 (Trial 232) - a phase 1, open label, uncontrolled, multiple-dose, age de-escalation trial to assess pharmacokinetics and safety of delamanid administered for 10 days to paediatric patients with presumed or confirmed MDR-TB receiving a WHO-recommended regimen and Study 242-12-233 (Trial 233) - a phase 2, open-label, multiple-dose trial to assess the safety, tolerability, pharmacokinetics, and efficacy of delamanid plus a WHO-recommended MDR-TB regimen in paediatric patients with MDR-TB over a 6-month treatment period. Thirteen patients were enrolled in Trial 232: 7 in Group 1 (12 – 17 years) and 6 in Group 2 (6– 11 years). All patients who completed the trial were enrolled in Trial 233.3,4
The primary objectives of Trial 233 were to assess the long-term safety and tolerability of delamanid and to characterise the pharmacokinetics of delamanid. Overall, delamanid was well tolerated in this cohort of paediatric patients and most frequently reported adverse events were headache (8 subjects [61.5%]), upper respiratory tract infection (7 subjects [53.8%]), and arthralgia (5 subjects [38.5%]). No deaths occurred during treatment with delamanid in both age groups.3 The frequency, type and severity of adverse reactions in children are expected to be the same as in adults.
Secondary trial objectives of Trial 233 included evaluation of delamanid efficacy: 12 of the 13 (92.3%) subjects had a favourable 24-month WHO final treatment outcome (cured or treatment completed) and 1 subject (7.7%) did not complete the study.3
About Deltyba® (delamanid)
Deltyba® (delamanid) inhibits the synthesis of mycolic acid, an essential component of mycobacterial cell walls.5 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.6 It has exhibited anti-TB efficacy and a favourable safety profile in multiple Otsuka-sponsored clinical trials, including two Phase 2 studies, an open-label Registry (Trials 204/208/116), and one Phase 3 study (Trial 213).7-9
About MDR/RR-TB
In 2018, an estimated 484,000 people acquired rifampicin-resistant TB (RR-TB), and of these, 78% had MDR-TB, a type of TB resistant to rifampicin and isoniazid.2 TB is one of the most dangerous 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.10,11
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 other Otsuka Group 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 .
###
Date of preparation: September 2020
ONP-DEL-2000013
1
Jenkins H, et al
. The burden of multidrug-resistant tuberculosis in children. Int J Tuberc Lung Dis. 2018; Vol.22(5)
2
World Health Organization. Global Tuberculosis Report 2019. Available at: https://apps.who.int/iris/bitstream/handle/10665/329368/9789241565714-eng.pdf?ua=1
(Last accessed: September 2020)
3
EudraCT. https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-004620-38/results
(Last accessed: September 2020)
4
EudraCT. https://www.clinicaltrialsregister.eu/ctr-search/search?query=242-12-232
(Last accessed: September 2020)
5
Matsumoto M, et al
. OPC-67683, a nitro-dihydro-imidazooxazole derivative with promising action against tuberculosis in vitro and in mice. PLoS Med. 2006 Nov;3(11):e466
6
Deltyba®
(delamanid) EU Summary of Product Characteristics (April 2020). Available at: https://www.ema.europa.eu/en/documents/product-information/deltyba-epar-product-information_en.pdf
(Last accessed: September 2020)
7
Gler M, et al. Delamanid for multidrug-resistant pulmonary tuberculosis. N Engl J Med 2012; 366: 2151-2160.
8
Skripconoka V, et a
l. Delamanid improves outcomes and reduces mortality in multidrug-resistant tuberculosis. Eur Respir J. 2013; 41:1393-400.
9
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(3):249-259.
10
Access to Medicine Foundation report "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: September 2020)
11
Ignatius E. and Dooley K. New Drugs for the Treatment of Tuberculosis Clin Chest Med. 2019: 40(4):811-827.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200921005391/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
Incyte Announces New Positive 54-Week Late-Breaking Data for Povorcitinib in Hidradenitis Suppurativa at the 2026 American Academy of Dermatology (AAD) Annual Meeting28.3.2026 20:00:00 CET | Press release
Phase 3 data from the STOP-HS program demonstrate povorcitinib’s substantial and durable clinical efficacy through Week 54 in patients with moderate to severe hidradenitis suppurativa (HS). Through Week 54, clinically meaningful and durable responses were observed across all groups in both STOP-HS1 and STOP-HS2, with up to 71.4% of patients achieving HiSCR50. Improvements in clinical responses across high stringent thresholds were observed, with up to 57% of participants achieving HiSCR75 and up to 29% of participants achieving HiSCR100. Povorcitinib treatment led to consistent reductions across key inflammatory lesion types, with full resolution (ANdT=0) achieved in up to 20% of patients. Additionally, clinically meaningful improvements in quality-of-life measures, including skin pain and fatigue, were observed at Week 54. The overall safety profile of povorcitinib through 54 weeks is consistent with previously reported data, and both doses were well tolerated. Incyte (Nasdaq:INCY) to
Takeda’s Zasocitinib Delivered Rapid and Durable Skin Clearance in a Convenient Once-Daily Pill, Affirming Promise to Reshape Psoriasis Care28.3.2026 20:00:00 CET | Press release
About 70% of patients treated with zasocitinib achieved clear or almost clear skin (sPGA 0/1) at week 16 in Phase 3 plaque psoriasis studies A significantly greater PASI 75 response rate versus placebo was observed as early as week 4 Safety profile consistent with Phase 2b studies with no new safety signals identified Takeda(TSE:4502/NYSE:TAK)today announced new data from the two pivotal Phase 3studies of zasocitinib (TAK-279), a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis (PsO).1 Presented as a late-breaking abstract at the 2026 American Academy of Dermatology (AAD) Annual Meeting, these data show that convenient once-daily oral zasocitinib demonstrated rapid and durable skin clearance with a safety profile consistent with Phase 2b studies.1,2 “Our goal in psoriasis treatment is clear or almost clear skin, and previously this has been achieved primarily with injectable therapies,” said Melinda Gooderham,
AAD 2026: Late-Breaking Nemolizumab Data Demonstrate Clinically Meaningful Benefits for Children Aged 2 to 11 With Moderate-to-Severe Atopic Dermatitis28.3.2026 16:00:00 CET | Press release
Pharmacokinetics, safety and efficacy clinical study data show that nemolizumab achieved clinically meaningful reductions in skin lesions and itch through Week 16, which were sustained up to a year in children aged 2 to 11 with moderate-to-severe atopic dermatitis1 These findings reinforce the previously established safety and efficacy of nemolizumab in adults and adolescents with moderate-to-severe atopic dermatitis, for which it is approved by multiple global regulatory authorities2,3 Up to 25% of children are affected by atopic dermatitis, and currently there are limited approved treatment options for children living with moderate-to-severe atopic dermatitis4,5 Galderma (SIX: GALD) today announced new phase II data showing that nemolizumab was well tolerated and effective in children (aged 2 to 11 years) with moderate-to-severe atopic dermatitis, with a clinically meaningful and sustained reduction in skin lesions and itch for up to a year.1 Results will be presented in a late-break
Angelalign Technology (6699.HK)Releases 2025 Results: Passion for Clinical Excellence Drives Worldwide Growth27.3.2026 20:56:00 CET | Press release
Angelalign Technology Inc. (6699.HK) (“Angel” or the “Company”) released its financial results for fiscal year 2025. During the reporting period, the Company continued to do well in both the global and China markets. Total case volume was 532,400, which increased 48.1%, revenue was USD 370.3 million, which increased 37.8%, and adjusted net profit was USD 43.8 million, which increased 63.0%. The results were driven by Angel’s passion for clinical excellence and its open and inclusive culture that empowers talented people to work together to meet customer needs, the Company said. Fox Hu, CEO of Angel, stated: “The clear aligner industry is complex and multidisciplinary. It requires top-tier technical and operational talent along with seamless collaboration among professionals from diverse geographies. Angel’s open and inclusive culture attracts professionals who share a passion for clinical excellence and a dedication to bringing outstanding products and services to customers. This melti
Axway Positioned as a Leader in the IDC MarketScape: Worldwide API Management 2026 Vendor Assessment27.3.2026 18:46:00 CET | Press release
Axway, a 74Software company (Euronext: 74SW) and global leader in federated API management and enterprise integration, has been named a Leader in the IDC MarketScape: Worldwide API Management 2026 Vendor Assessment.1 Axway Amplify securely connects, orchestrates, and automates data integration. Organizations in financial services, manufacturing, healthcare, and other industries rely on Amplify to modernize integrations and confidently unlock data to deliver superior digital services faster. The report notes: “The platform benefits from Axway’s long-standing experience in B2B integration, secure file transfer, and legacy connectivity, providing differentiated capabilities for organizations that need to expose and control APIs around core systems that are not cloud-native.”1 This multi-pattern expertise in security, integration, and federated governance — built during the early phases of the API-driven digital transformation — becomes especially critical as enterprises seek to govern dat
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