Business Wire

CHMP grants positive opinion in the European Union for Otsuka’s child-friendly 25 mg dispersible tablet formulation of Deltyba® (delamanid) for the paediatric population weighing at least 10 kg with pulmonary multi-drug resistant tuberculosis

Share

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

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Robert Dornheim
Managing Director and CEO
Global TB Projects
Otsuka Novel Products GmbH
Email: RDornheim@otsuka-onpg.com
Telephone: +49 89 2060205-50

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

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

SAB Biotherapeutics Announces SAB-185 Receives Positive DSMB Review and Advances to Phase 3 in NIH-Sponsored ACTIV-2 Trial for Treatment of COVID-1924.9.2021 14:00:00 EEST | Press release

SAB Biotherapeutics (SAB), a clinical-stage biopharmaceutical company with a novel immunotherapy platform that produces specifically targeted, high-potency, fully-human polyclonal antibodies without the need for human donors, today announced that an independent Data Safety Monitoring Board (DSMB) has completed its prespecified interim analysis data review of the safety and efficacy of SAB-185 in the Phase 2 portion of the ACTIV-2 trial and has recommended advancement to Phase 3. SAB-185 is a fully-human, specifically-targeted, broadly-neutralizing polyclonal antibody therapeutic candidate for the treatment of non-hospitalized patients with mild to moderate COVID-19. It is being assessed in the ACTIV-2 trial funded and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH) in collaboration with the AIDS Clinical Trials Group. SAB-185 is advancing to the Phase 3 trial based on meeting pre-defined graduation crite

NTHU Researchers Develop Ultrasonic Vortex Thrombolytic Device24.9.2021 12:00:00 EEST | Press release

As COVID-19 vaccination has raised the issue of thrombosis, Dr. Chih-Kuang Yeh, Distinguished Professor of the Department of Biomedical Engineering and Environmental Sciences, has led a research team to developed the world's first ultrasonic vortex thrombolytic device and to treat thrombosis quickly and safely. The research has been published in Proceedings of the National Academy of Sciences (PNAS) in 2021. Moreover, U.S. and EU patents are granted, with more applications on the way. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210924005015/en/ (Photo: National Tsing Hua University) The device is developed to solve two common thrombosis called pulmonary embolism (PE) and deep vein thrombosis (DVT), which have global prevalence of 10 million new cases annually. DVT is the main cause of PE, and PE can cause heart failure and has mortality rate up to 65%. Professor Yeh explained that the current treatment options includes dr

Long-Term CRYSVITA® ▼ (burosumab) Treatment Reduces the Burden of Disease in Adults With X-Linked Hypophosphataemia (XLH), a Rare Genetic Metabolic Bone Disease24.9.2021 11:00:00 EEST | Press release

Kyowa Kirin Co., Ltd. (TSE:4151, Kyowa Kirin) today announced the publication of new data highlighting the sustained benefits of treatment with CRYSVITA® (burosumab) in adults with X-linked hypophosphataemia (XLH), a rare genetic metabolic bone disease. The data show that adults with XLH experience substantial pain, stiffness, fatigue and impairment in physical and ambulatory function. Treatment with CRYSVITA was associated with a significant improvement from baseline after 96 weeks.1 The data are from a randomised, double-blind, placebo-controlled, phase 3 study with an open-label extension to assess the efficacy and safety of CRYSVITA in adults with XLH.2 The study met its primary endpoint, showing a statistically significant effect in increasing serum phosphorus concentrations at 24 weeks, compared to placebo.3 After 24 weeks, all patients were switched to CRYSVITA treatment and data was collected on metabolic and biochemical markers, patient reported outcomes (PROs) and measures of

XPeng Backed HT Aero Unveils Flying Vehicle City Usage Scenarios24.9.2021 08:58:00 EEST | Press release

HT Aero, an urban air mobility (UAM) company in which XPeng Inc. is an investor, today unveiled future urban usage scenarios for its fifth-generation flying vehicle XPeng X2 ("X2"), including autonomous flight take-off and landing for specific city scenarios, back-end scheduling, charging and flight control. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210923006034/en/ XPeng X2 flying vehicle (Photo: Business Wire) XPeng X2 will present at the 13th Airshow China 2021, starting on September 28 in Zhuhai, Guangdong Province. X2 is equipped with a robust, highly intelligent flight control system and superior autonomous flying capability, able to conduct autonomous flight route planning, all-round real-time imaging, real-time flight monitoring, two-way real-time communications, all-round environmental perception and autonomous return and landing. It is powered by a highly efficient and convenient charging system, leveraging XP

Valbiotis Consolidates Its Development of Innovative Natural Health Solutions by Integrating the Exploration of Microalgae Produced in New Caledonia, Through an Exclusive Agreement With ADECAL-Technopole and IFREMER24.9.2021 08:35:00 EEST | Press release

Regulatory News: Valbiotis (FR0013254851 – ALVAL, PEA/SME eligible), a French research and development company committed to scientific innovation for preventing and combating of metabolic diseases, announces the consolidation of its development of innovative natural health solutions, by integrating the exploration of microalgae produced in New Caledonia, through an exclusive agreement with ADECAL-Technopole and IFREMER. This program should allow to develop a bank of high-potential strains selected by ADECAL-Technopole and IFREMER since 2013 in New Caledonia as part of the "AMICAL" joint research project. Valbiotis will carry out the work necessary to demonstrate the health benefits of these microalgae strains at its preclinical platform in Riom, with a view to filing new patents. Once this scientific validation has been achieved, production will be ensured in New Caledonia for the industrial scale-up, thanks to existing and operational pilot infrastructure for which the technology and

Illumination and Nintendo Announce Theatrical Release Date and Voice Cast for the Super Mario Bros. Animated Film24.9.2021 02:46:00 EEST | Press release

Illumination (HQ: Santa Monica, CA, USA; Founder and CEO: Chris Meledandri) and Nintendo Co., Ltd. (HQ: Kyoto, Minami-ku, Japan; Representative Director and President: Shuntaro Furukawa, “Nintendo” hereafter) today announced that their new animated film based on the world of Super Mario Bros. will be released worldwide during the 2022 holiday season. Universal Pictures will release the film in North America on December 21, 2022, with the release schedule for additional countries and regions to be announced at a future date. The film will be co-financed by Universal Pictures and Nintendo. In addition, the two companies announced the voice actors for the characters Mario (Chris Pratt), Princess Peach (Anya Taylor-Joy), Luigi (Charlie Day), Bowser (Jack Black), Toad (Keegan-Michael Key), Donkey Kong (Seth Rogen), Cranky Kong (Fred Armisen), Kamek (Kevin Michael Richardson) and Spike (Sebastian Maniscalco). Each voice actor was cast for their ability to capture the unique spirit of their c

NuScale Power Signs Memorandum of Understanding with Getka and UNIMOT to Explore SMR Deployment in Poland23.9.2021 20:00:00 EEST | Press release

NuScale Power, Getka Group (Getka) and UNIMOT S.A. (UNIMOT) announced today the three companies have signed a Memorandum of Understanding (MOU) with business purposes including to explore the deployment of NuScale’s small modular reactor (SMR) technology as a coal repurposing solution for existing coal-fired power plants in Poland. Getka is an Oklahoma-based integrated energy company providing construction, and delivery of petroleum, refined products, and alternative energy. Through its Zero Impact Strategy, Getka is focused on reducing emissions output through renewable energy. UNIMOT is a Poland-based multi-energy Capital Group that offers its wholesale and retail customers fuel products, gas and electricity, including renewable energy. This agreement demonstrates the value of international partnership and collaboration in utilizing NuScale’s SMR technology to repurpose coal plants across the country. This press release features multimedia. View the full release here: https://www.bus

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