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
NetApp Helps Customers Accelerate Adoption of Latest VMware Cloud Foundation Innovations2.9.2026 22:30:00 CEST | Press release
NetApp solutions validated to support VCF 9.1, giving mutual customers access to a modern private cloud with enterprise-grade data management, cyber resilience, and cost-efficient scaling NetApp® (NASDAQ: NTAP), the Intelligent Data Infrastructure company, announced new capabilities in NetApp ONTAP® have been tested and validated to support VMware Cloud Foundation (VCF) 9.1, giving customers an optimized and secure data infrastructure foundation for their private and hybrid clouds. By combining the advanced capabilities of VCF 9.1 with cost-effective and enterprise data management with built-in security features from NetApp, including safeguarding data against ransomware attacks with rapid recovery, mutual customers can lower costs and accelerate the deployment of their AI software into production. VMware Cloud Foundation 9.1 provides enterprises with a unified private cloud platform for running both traditional and modern workloads. NetApp's solutions are tested and validated to suppo
Venture Global Announces Closing of $3,000,000,000 364-Day Senior Secured Revolving Credit Facility2.9.2026 22:30:00 CEST | Press release
Venture Global, Inc. (“Venture Global”) announced today that its subsidiary Venture Global LNG, Inc. (“VGLNG”) has entered into a new, $3,000,000,000 364-day revolving credit facility (the “Facility”). Venture Global expects to use the proceeds from borrowings under the Facility for general corporate purposes of VGLNG and its subsidiaries, including to fund certain project costs for the CP2 and Plaquemines bolt-on expansions prior to their respective FIDs. Bank of America, N.A. served as Coordinating Lead Arranger and Sole Bookrunner and will also serve as Administrative Agent. BBVA, Goldman Sachs, ING, J.P. Morgan, Mizuho, MUFG, NBC, RBC, Scotia, SMBC, U.S. Bank, and Wells Fargo served as Coordinating Lead Arrangers and Barclays, Santander, and Deutsche Bank served as Joint Lead Arrangers. About Venture Global Venture Global is an American producer and exporter of low-cost U.S. liquefied natural gas (LNG) with over 100 MTPA of capacity in production, construction, or development. Vent
Invivoscribe Begins Commercial Shipments of PrepQuant™ Systems, Enabling High-Sensitivity Sample Preparation for MRD Testing2.9.2026 21:31:00 CEST | Press release
New automated platform is designed to improve the quality, efficiency, and consistency of DNA extraction and concentration from large-volume blood and plasma samples, supporting downstream assays capable of detecting disease-associated signals at MRD sensitivity levels. Invivoscribe®, a global leader in precision diagnostics and measurable residual disease (MRD) testing, today announced that commercial shipments of the PrepQuant™ System have begun in North America. First unveiled at the American Association for Cancer Research Annual Meeting in April 2026, PrepQuant is now being delivered to customers, marking the platform's progression from development and validation into commercial deployment. The commercial milestone extends Invivoscribe's capabilities into laboratory instrumentation and addresses a critical bottleneck in highly sensitive molecular testing: efficiently recovering, concentrating, and quantifying DNA from larger blood and plasma inputs. PrepQuant is assay agnostic, de
C.H. Guenther Opens Centre of Excellence in Coventry, UK to Accelerate Bakery Innovation and Support Future Manufacturing Growth Across UK and Europe2.9.2026 18:00:00 CEST | Press release
C.H. Guenther & Son LLC (“C.H. Guenther” or “CHG”), a leading food manufacturer, has opened a new Centre of Excellence (the “Centre”) at its flagship Coventry bakery, creating a dedicated innovation and customer collaboration hub designed to accelerate the development of premium bakery products across the UK and Europe. The new facility has been designed to support CHG’s customers including leading global quick service restaurants, foodservice operators and retailers as they develop, test and refine new bakery products. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260902696890/en/ The purpose-built, 172-square-metre Centre of Excellence brings together a commercial-scale bakery, customer demonstration kitchen, sensory evaluation facilities, innovation suite and dedicated collaboration spaces in one specialized location. Designed to support and accelerate product development from concept through to commercial manufacturing,
Record Asset Management Enters New Phase of Growth2.9.2026 17:35:00 CEST | Press release
Record Asset Management GmbH (“RAM”), a subsidiary of London-listed Record plc (“Record” or the “Group”), is pleased to announce that it is now operating cashflow positive, thereby marking a transition from its investment phase into a growth business within the Group, and a significant milestone towards sustainable profitability. RAM is the European asset management arm of Record, the London-listed specialist investment group managing USD 122 billion of assets on behalf of institutional clients worldwide. Record's client base comprises pension funds, foundations, sovereign institutions and other asset managers, with whom the Group has built long-standing relationships through its focus on bespoke investment and risk management solutions. RAM was established as a sister company to Record’s core currency business and obtained its BaFin license in 2022. RAM has grown rapidly in the last two years and has developed into a diversified private markets platform with dedicated infrastructure e
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