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
Axelspace’s Seven GRUS-3 Earth Observation Microsatellites Successfully Launched and First Signals Received8.7.2026 07:00:00 CEST | Press release
Axelspace Corporation (“Axelspace”), a leading developer and operator of microsatellites dedicated to realizing its vision of “Space within Your Reach,” announced that the seven GRUS-3 next-generation Earth observation microsatellites were successfully launched and that the first radio signals were successfully received. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260707291751/en/ The successful launch of Falcon 9 ©SpaceX GRUS-3 was integrated via Exolaunch and launched aboard a SpaceX Falcon 9 rocket from Vandenberg Space Force Base in California, USA, on July 7, 2026 at 07:12 (UTC) during the Transporter-17 rideshare mission. The satellites were successfully put into their intended orbit. Axelspace received the first radio signals from all the seven satellites in orbit. The satellites are currently operating normally. Axelspace is working toward completing the critical operation of the GRUS-3 microsatellite to ensure pr
QpiAI Open-Sources Its Quantum SDK to Accelerate Global Quantum Software Development8.7.2026 06:30:00 CEST | Press release
QpiAI, a globally leading full-stack quantum computing company, today released the QpiAI Quantum SDK as open-source software. Available now at https://github.com/qpiai/quantum-sdk, the QpiAI Quantum SDK gives developers, researchers, and startups an accessible, developer-friendly toolkit to build and run quantum algorithms and to connect their quantum development workflows directly to QpiAI's 8-qubit and 25-qubit quantum computers through QpiAI-QCloud (https://qcloud.qpiai.tech/). The release is designed to expand access to quantum software development for developers, researchers, universities, startups, and enterprise innovation teams worldwide. By open-sourcing the SDK, QpiAI is giving the global quantum community a practical foundation for building industry-specific quantum solutions across finance, logistics, materials, chemistry, security, AI, optimization, and advanced scientific computing. The QpiAI Quantum SDK provides a Python-based interface for circuit creation, simulation,
Access Advance Welcomes Wave of New Licensees to the HEVC Advance Patent Pool8.7.2026 02:00:00 CEST | Press release
Access Advance LLC, the leading HEVC patent pool administrator, today announced a significant expansion of the HEVC Advance Patent Pool, with 28 companies executing licenses in the first half of 2026. The new Licensees span consumer electronics, automotive, telecommunications, industrial technology, and professional security, reflecting the breadth of industries in which HEVC has become a foundational video technology. "HEVC remains the cornerstone of modern video delivery, and the demand we are seeing from new Licensees speaks to the long-term commercial relevance of this technology," said Peter Moller, CEO of Access Advance. "HEVC licensing activity has been consistently strong, and we are pleased to welcome a number of important new participants to the program." Notably, nine video surveillance equipment manufacturers have joined the HEVC Advance program as Licensees, ranging from three of the world's largest video surveillance equipment makers to specialized developers of security
Empire State Building Observation Deck Run-Up Returns for 48th Annual Race on Oct. 68.7.2026 00:22:00 CEST | Press release
Presented by NYU Langone Health and Powered by MerrellLottery Open Through July 20 The Empire State Building Observation Deck (ESB), atop the “World’s Most Famous Building,” today announced that general lottery registration is open for this year's Empire State Building Observation Deck Run-Up (ESBRU), which will run through July 20, 2026. The annual race, presented by NYU Langone Health and powered by Merrell, will take place on Oct. 6, 2026, at 8 p.m. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260707902561/en/ Empire State Building Observation Deck Run-Up Returns for 48th Annual Race on Oct. 6 This year’s race marks the 48th anniversary of the event, in which 225 runners will race up 1,576 stairs of the iconic New York City landmark to reach the world-famous 86th Floor Observation Deck. “Every year, the Empire State Building Observation Deck Run-Up is a remarkable feat for all who participate as they race up to Tripadvi
Modon's Hudayriyat Golf Estates Sets UAE Record With More Than AED 13 Billion in Sales Within Days of Launch7.7.2026 20:36:00 CEST | Press release
A record-breaking sales value for a residential project in the UAEThe project comprises golf mansions, villas, and townhouses across Hudayriyat Island, Abu Dhabi1,700 residences sold within days after the launch15% non-UAE resident buyers81% new customers to Modon Modon has set a new benchmark for the UAE real estate market with the launch of Hudayriyat Golf Estates on Hudayriyat Island, Abu Dhabi. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260707126559/en/ Modon's Hudayriyat Golf Estates sets UAE record with more than AED 13 billion in sales within days of launch (Photo: AETOSWire) Within days of launch, the community achieved record-breaking sales exceeding AED 13 billion, marking the highest publicly recorded sales value for a single residential project launch in the UAE. Comprising an exclusive collection of golf mansions, villas, and townhouses, the development saw 1,700 of its residences sold after few days of laun
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