KYOWA-KIRIN-CO.,-LTD.
12.11.2021 13:36:13 CET | Business Wire | Press release
Kyowa Kirin Co., Ltd. (TSE:4151, President and CEO: Masashi Miyamoto, “Kyowa Kirin”) today announced that following a re-examination procedure the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a negative opinion for istradefylline as an add-on treatment to levodopa (L-Dopa) based regimens in adults living with Parkinson’s, experiencing end-of-dose motor fluctuations. Parkinson’s is a chronic, progressive neurodegenerative condition that affects small regions in the brain that control movement, balance and posture.1 It is the fastest growing neurodegenerative disorder in the world.2
“We are disappointed by the CHMP opinion. We will take time to assess our plans for istradefylline in EMEA,” said Tomohiro Sudo, Executive Officer, Head of Global Product Strategy Department at Kyowa Kirin. “We appreciate the collaboration we have had with all stakeholders and applaud the Parkinson’s community for their commitment to supporting people living with this chronic, debilitating condition.”
The Kyowa Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies. The company is committed to bringing our innovative therapies to patients.
About istradefylline
Istradefylline was developed as a novel, first-in-class non-dopaminergic, adenosine A2A receptor antagonist that reduces ‘OFF’ time in people living with Parkinson’s through selective targeting of adenosine A2A receptors in the basal ganglia. Whilst dopaminergic treatment targets the dopamine receptors in the direct and indirect pathways to facilitate movement, istradefylline, as an add-on to L-Dopa, reduces the activity of the indirect pathway which suppresses movement.3,4 Consequently, it helps restore the balance within the basal ganglia.1,2
About Parkinson’s and ‘OFF’ episodes
There are an estimated 10 million people in the world currently living with Parkinson’s.5 Although it is classically characterised by motor symptoms (symptoms involving movement), people living with the condition also experience a large range of non-motor symptoms, which add to the complexity of living with the condition.5 Although Parkinson’s is not life threatening there is currently no cure.1 Over time symptoms progress and can be unpredictable, imposing a significant impact on daily life.1 This impact can extend to caregivers, friends and family, whose own wellbeing and quality of life can deteriorate as a result.6
‘OFF’ episodes is used to describe the return of Parkinson’s symptoms, also known as ‘OFF’ symptoms, and can be triggered by a variety of phenomena, including:7
- Delayed onset of response to medication
- Reduced duration of benefit from a medication
- Reduced or no efficacy of a dose of medication
About Kyowa Kirin
Kyowa Kirin strives to create and deliver novel medicines with life-changing value. As a Japan-based Global Specialty Pharmaceutical Company with a more than 70-year heritage, we apply cutting-edge science including an expertise in antibody research and engineering, to address the needs of patients and society across multiple therapeutic areas including Nephrology, Oncology, Immunology/Allergy and Neurology. Across our four regions – Japan, Asia Pacific, North America and EMEA/International – we focus on our purpose, to make people smile, and are united by our shared values of commitment to life, teamwork/Wa, innovation, and integrity. You can learn more about the business of Kyowa Kirin at: https://www.kyowakirin.com/ .
Kyowa Kirin International is a subsidiary of Kyowa Kirin Co., Ltd.
Kyowa Kirin International
http://www.international.kyowa-kirin.com /
Galabank Business Park
Galashiels, TD1 1QH
United Kingdom
References
1. European Parkinsons Disease Association. About Parkinson’s, https://www.epda.eu.com/about-parkinsons/what-is-parkinsons/ [Last accessed Novemeber 2021].
2. Dorsey ER, Sherer T, Okun MS, et al. The Emerging Evidence of the Parkinson Pandemic. J Parkinsons Dis 2018; 8: S3-s8. 2018/12/26. DOI: 10.3233/jpd-181474.
3. Saki M, Yamada K, Koshimura E, et al. In vitro pharmacological profile of the A2A receptor antagonist istradefylline. Naunyn Schmiedebergs Arch Pharmacol 2013; 386: 963-972. 2013/07/03. DOI: 10.1007/s00210-013-0897-5.
4. LeWitt PA, Aradi SD, Hauser RA, et al. The challenge of developing adenosine A(2A) antagonists for Parkinson disease: Istradefylline, preladenant, and tozadenant. Parkinsonism Relat Disord 2020; 80 Suppl 1: S54-s63. 2020/12/23. DOI: 10.1016/j.parkreldis.2020.10.027.
5. Ball N, Teo W-P, Chandra S, et al. Parkinson's Disease and the Environment. Frontiers in Neurology 2019; 10. Mini Review. DOI: 10.3389/fneur.2019.00218.
6. Armstrong MJ, Rastgardani T, Gagliardi AR, et al. The impact of off periods on persons with Parkinson’s and care partners: a qualitative study. Neurol Clin Pract 2020;10.1212/CPJ.0000000000000921.
7. Freitas ME, Hess CW and Fox SH. Motor Complications of Dopaminergic Medications in Parkinson's Disease. Semin Neurol 2017; 37: 147-157. 2017/05/17. DOI: 10.1055/s-0037-1602423.
KKI/INT/IST/0142
Date of preparation: November 2021
View source version on businesswire.com: https://www.businesswire.com/news/home/20211112005565/en/
Link:
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
Labaton Keller Sucharow LLP Launches Corporate Accountability & Governance Task Force13.7.2026 16:46:00 CEST | Press release
Labaton Keller Sucharow LLP is pleased to announce the launch of its new Corporate Accountability & Governance Task Force, designed to help institutional investors advance corporate accountability while pursuing meaningful shareholder recoveries. Created in response to the increasing needs of our clients, the Task Force will provide clients with strategic advice on opportunities to drive positive corporate change through securities and shareholder litigation. This initiative reflects the Firm’s longstanding commitment to protecting investor interests while promoting responsible corporate conduct. Labaton partners with institutional investor clients to pursue cases that not only seek financial recovery but also encourage meaningful corporate reforms and reinforce sound governance practices. The Task Force is chaired by Partners Carol C. Villegas and Domenico “Nico” Minerva, who have led some of the Firm's most significant matters involving corporate accountability and governance reform.
FlexTrade Expands Portfolio Risk and Analytics Capabilities Through Strategic Partnership with Portx13.7.2026 15:30:00 CEST | Press release
The collaboration expands FlexTrade’s front-office risk analytics offering, connecting portfolio construction, risk insight, and trading decisions in a unified buy-side workflow. FlexTrade Systems (@FlexTrade), a global leader in multi-asset execution and order management systems, and Portx, an advanced portfolio construction and analytics provider, today announced the integration of Portx’sreal-time portfolio construction, optimization, and risk analytics capabilities into FlexTrade’s integrated buy-side order and execution management system (OEMS), FlexONE. The partnership comes as buy-side firms place greater emphasis on real-time risk management across increasingly complex portfolios, advanced hedging strategies, and supporting operating models. For hedge funds and institutional asset managers, particularly those running multi-strategy or multi-asset approaches, the ability to assess portfolio risk, review pro forma exposures, and act on those insights within the order and executio
Xsolla Connect Returns to Brighton13.7.2026 15:22:00 CEST | Press release
Connecting The UK Game Development Community For Networking And Insights During Develop:Brighton Xsolla, a global video game commerce company, today announced the launch of an exclusive networking event for the UK game development community, Xsolla Connect, taking place with Develop:Brighton 2026 on July 15, 2026. Designed to bring together independent and mid-tier developers, publishers, investors, and industry professionals, the event will offer a focused evening of meaningful connections and actionable insights at one of the UK’s most important annual games gatherings. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260713748542/en/ Graphic: Xsolla Develop:Brighton has long served as a cornerstone of the European video games industry, drawing developers, publishers, investors, and studio leaders from across the UK and beyond to share knowledge, explore opportunities, and forge lasting business relationships. Xsolla’s event
Niagen Bioscience Receives Exclusive U.S. FDA Rare Pediatric Disease (RPD) Designation and European Medicines Agency Orphan Medicinal Product Designation (OMPD) for NB4168 for the Treatment of Ataxia Telangiectasia (A-T)13.7.2026 14:32:00 CEST | Press release
Regulatory recognition in the United States and Europe supports the development of NB4168, a novel small molecule candidate for a rare pediatric disease with no approved treatments Niagen Bioscience, Inc. (NASDAQ: NAGE), the global authority on NAD+ (nicotinamide adenine dinucleotide) with a focus on the science of healthy aging, today announced that the U.S. Food & Drug Administration (FDA) granted Rare Pediatric Disease (RPD) Designation for its proprietary lead small molecule drug candidate NB4168 for the treatment of Ataxia Telangiectasia (A-T). NB4168 is an oral small molecule therapy engineered to deliver substantially greater nicotinamide riboside (NR) exposure than conventional NR while maintaining a differentiated pharmacokinetic and safety profile. In addition, the European Medicines Agency (EMA) has granted Orphan Medicinal Product Designation (OMPD) to NB4168 for the treatment of A-T, providing regulatory recognition in the European Union and further supporting the Company'
SLB OneSubsea Awarded EPC Contract for Eni’s Baleine Phase 3 Project Offshore Côte d'Ivoire13.7.2026 14:00:00 CEST | Press release
Integrated subsea production system and local capabilities enable accelerated deepwater development Global energy technology company SLB (NYSE: SLB) announced today that its OneSubsea™ joint venture has been awarded a major multi-well engineering, procurement, and construction (EPC) contract by Eni for Phase 3 of the deepwater Baleine project offshore Côte d’Ivoire. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260712734539/en/ SLB OneSubsea™ joint venture has been awarded a major multi-well engineering, procurement, and construction (EPC) contract by Eni for Phase 3 of the deepwater Baleine project offshore Côte d’Ivoire. Under the contract, SLB OneSubsea will deliver complete subsea production systems (SPS) for 13 wells, reinforcing its role as a core technology and execution partner on one of the most strategically significant offshore developments currently underway in the region. The EPC scope includes subsea trees, um
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