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
ABB strengthens electrical engineering advisory capabilities in Europe with Premium Power acquisition13.2.2026 10:30:00 CET | Press release
Acquisition strengthens ABB’s ability to deliver system-level advisory support at scale to help critical industries manage increasingly complex electrical infrastructures and safeguard energy resilience Enhances ABB’s Electrification Service division offering in power system studies, grid modelling and electrical risk management for data centers, pharmaceuticals and other critical industries Solidifies ABB at the electrical system level, embedding trusted advisory expertise at the point where operational risks, resilience and performance are defined ABB today announced it has entered into an agreement to acquire Premium Power, a leading electrical engineering consultancy headquartered near Dublin, Ireland. For more than two decades, Premium Power has established its reputation as a trusted advisor to large customers, particularly in data centers, pharmaceutical manufacturing and other mission-critical sectors where electrical resilience, uptime and regulatory compliance are essential.
EnergyAustralia, Enerven and NHOA Energy Mark Financial Close and Project Launch of the 245 MWh Hallett Battery in South Australia13.2.2026 08:00:00 CET | Press release
The project will support grid stability in the National Electricity Market, strengthening NHOA Energy’s long-term commitment to the Australian market NHOA Energy, global provider of utility-scale energy storage systems, today marked together with EnergyAustralia and Enerven the official project launch of a 245 MWh Battery Energy Storage System (BESS) in Hallett, near the town of Canowie, in South Australia, following the achievement of financial close and the project’s transition into the delivery phase. The milestone was announced today during a project launch ceremony held at the Hallett Power Station, attended by representatives of EnergyAustralia, Enerven, NHOA Energy, government, Traditional Owners and local community stakeholders. Owned and developed by EnergyAustralia, the Hallett BESS is being built alongside the existing Hallett gas-fired power station and represents the first stage of a broader site development. As delivery partner for Stage 1 of the project, NHOA Energy will
Echoworx Encryption Arrives on AWS Marketplace: Frictionless Security for a Global World13.2.2026 07:00:00 CET | Press release
Echoworx, the trusted name in email encryption, is now live on AWS Marketplace—fully deployed on AWS infrastructure. For global businesses, this means securing sensitive communications just got a whole lot easier, starting from purchase. Why AWS Marketplace? Why Now? Echoworx’s mission has always been to make secure communications as easy and accessible as possible. By joining the AWS Marketplace, Echoworx is taking this mission a step further, ensuring that customers can procure its encryption solution with the same ease and efficiency they experience when using it. Cross-border compliance, taxes, and billing headaches slow teams down. With AWS Marketplace, Echoworx customers bypass the usual red tape: automated tax and regulatory handling, simple multi-currency billing, and support for Private Offers. That translates to custom pricing and contracts in local currencies, less foreign exchange guesswork, and a procurement process built for modern enterprise. "Our partnership with AWS Ma
Align Partners Issues Formal Shareholder Proposals to Gabia13.2.2026 01:37:00 CET | Press release
Align Partners Capital Management Inc. (“Align Partners”), a shareholder of Gabia, Inc. (“Gabia” or the “Company”), has submitted formal shareholder proposals for inclusion in the agenda of Gabia’s upcoming 27th Annual General Meeting (“AGM”) and issued a call for strengthened governance practices to address the Company’s persistent undervaluation. Align Partners noted that, as shareholder proposals will be presented at this year’s AGM, Gabia should follow the Korea Exchange (KRX) Corporate Governance Key Indicators by publishing the AGM convocation notice at least four weeks prior to the meeting date. Align Partners emphasized that last year’s AGM notice was issued only 16 days before the meeting, limiting shareholders’ ability to adequately review the agenda and exercise informed voting rights. Gabia is widely recognized as a leading Korean IT services and cloud infrastructure company with solid operating performance. Despite these strengths, Align Partners believes the Company conti
Andersen Consulting udvider sin platform i Nordamerika med tilføjelsen af Kezber12.2.2026 22:50:00 CET | Pressemeddelelse
Andersen Consulting styrker sine ydelser inden for forretningstransformation og cybersikkerhed med tilføjelsen af den canadisk-baserede samarbejdsvirksomhed Kezber. Kezber blev stiftet i 1996 og specialiserer sig i at levere en komplet pakke af it-løsninger, herunder managed it-services, infrastruktursupport, cybersikkerhed, cloudtjenester, specialudviklet software, business intelligence og ai-tjenester samt automatisering af forretningsprocesser. Firmaet samarbejder med organisationer med henblij på at øge produktiviteten, modernisere deres teknologiske miljøer og udnytte datadrevne løsninger til at nå strategiske mål. "Vores samarbejde med Andersen Consulting giver os mulighed for at inddrage hele vores pakke af software og it-tjenester i en bredere konsulentramme," udtaler Alan Kezber, administrerende direktør for Kezber. "Ved at integrere vores tekniske ekspertise med Andersen Consultings omfattende konsulentkompetencer kan vi tilbyde kunderne løsninger, der skaber driftsforbedring
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