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
Nexo Reaffirms EU Compliance28.7.2026 16:00:00 CEST | Press release
The digital assets wealth platform announces sustained operations across the European Economic Area in the MiCA era Nexo, a leading digital assets wealth platform, today reaffirmed product compliance across the European Economic Area (EEA), achieved ahead of MiCAR’s entry into force. The company operates with a local setup through two MiCAR-licensed partners bringing technical depth and operational maturity to Nexo's client-facing platform in the region. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260728038475/en/ Nexo's setup pairs its global wealth platform with dedicated, licensed European infrastructure — splitting custody and brokerage across two regulated partners: Tangany, licensed under MiCAR, provides institutional-grade custody infrastructure for digital assets. Meanwhile, DLT Finance, licensed under MiCAR and authorized under MiFID II, provides brokerage infrastructure for digital assets and financial instrumen
Estée Lauder Announces New Fragrance, Glimmer, with Global Campaign Starring Hailee Steinfeld28.7.2026 16:00:00 CEST | Press release
Today, Estée Lauder announces the launch of Glimmer, a new prestige fragrance created for a new generation of consumers. An amber floral fragrance with a gourmand twist, Glimmer transforms the power of everyday "glimmers” - small moments of joy, hope, and connection - into a sensorial fragrance experience designed to inspire optimism, foster community, and leave a lasting impression. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260727469772/en/ Hailee Steinfeld stars as the face of Glimmer Acclaimed actress and singer Hailee Steinfeld stars as the face of Glimmer. Rooted in the belief that one spark can ignite many, the campaign positions Hailee and her singing voice as catalysts for the joy, optimism, and connection that are at the heart of Glimmer. “Hailee is the embodiment of what Glimmer represents; she is confident, has a contagious sense of joy, and understands the power of connecting with her community,” said Justin
Interactive Brokers Opens AI Connectivity to Any Tool Built on the MCP Standard28.7.2026 16:00:00 CEST | Press release
Clients can now connect their accounts to the AI tools they already use, built on the open Model Context Protocol standard Interactive Brokers (Nasdaq: IBKR), an automated global broker, today announced that clients can now connect their accounts to nearly any AI tool they already use. Previously limited to the certified marketplaces for ChatGPT, Claude, and Grok, clients can now also connect from a growing range of tools that support the Model Context Protocol (MCP), including Claude Code, Cursor, Perplexity, and Windsurf. MCP has become the common standard for connecting AI applications to outside services. Interactive Brokers' AI Integration has been built on MCP since launch, and clients can now connect from any MCP-compatible tool in addition to the certified marketplaces. “Interactive Brokers has long offered open APIs that let clients connect their accounts to the tools and systems they choose,” said Milan Galik, Chief Executive Officer of Interactive Brokers. “Supporting AI too
Mindbreeze InSpire Reduces Token Maxxing, Turning Runaway AI Costs Into Predictable Enterprise Value28.7.2026 15:03:00 CEST | Press release
By grounding generative AI in precise, governed enterprise knowledge, Mindbreeze InSpire cuts the wasted tokens that inflate AI budgets and erode answer quality. Mindbreeze, a leading global provider of AI-based knowledge management solutions, today announced that Mindbreeze InSpire reduces token maxxing, the costly overconsumption of large language model (LLM) tokens that is straining enterprise AI budgets. By retrieving only the most relevant, grounded content and passing it to LLMs with precision, Mindbreeze InSpire lowers the tokens required per answer while improving accuracy, giving enterprises a path to scalable AI with predictable economics. Token maxxing has become one of the most underestimated risks in enterprise AI. As organizations connect generative AI to their data, many default to injecting large volumes of undifferentiated context into every prompt, repeatedly, across thousands of queries. Industry analysis has warned that tokens are becoming the true unit of AI cost,
Uptime Institute 16th Annual 2026 Global Data Center Survey: Deployment of High Density Racks Rising Fast, Operators Face Continued Recruiting and Retention Pressures28.7.2026 15:02:00 CEST | Press release
Uptime Institute today released the findings of its 16th Annual Global Data Center Survey, the most comprehensive study of the digital infrastructure sector. The 2026 results reveal an industry navigating workforce constraints, escalating outage expenses, even as rising costs remain the top concern for management teams. Financial Pressure and Resource Constraints Intensify: While high costs continue to be a primary concern for data center leaders, the 2026 survey also highlights escalating concerns over capacity forecasting, power availability, and supply chain disruptions. Power efficiency gains remain gradual. The industry saw minor improvements in average Power Usage Effectiveness (PUE) levels this year. While newer facilities may boast highly efficient designs, overall global progress is slowed by legacy infrastructure. The AI and Density Reality Check: Despite market enthusiasm for Artificial Intelligence, expectations for AI in data center operations cooled slightly in 2026. Oper
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