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
PPAI Releases Landmark Study Showing Branded Merchandise Supports a $472 Billion Global Economic Footprint9.9.2026 19:24:00 CEST | Press release
First-of-its-kind Oxford Economics study reveals annual spending, jobs and tax contributions Branded merchandise connects brands and people every day, but its impact extends well beyond the products consumers wear, use, receive or purchase. A landmark study commissioned by Promotional Products Association International (PPAI) provides the first comprehensive look at the global economic ecosystem behind branded merchandise. Conducted by independent global advisory firm Oxford Economics, the Branded Merchandise Global Market Report measures the industry end to end, from manufacturing and decoration to distribution, retail, e-commerce, fulfillment, marketing and brand activation. Key findings: $338.3 billion was spent on branded merchandise globally in 2025. The industry supported $472.3 billion in global GDP. Branded merchandise supported 11.9 million jobs worldwide. The sector supported $141.3 billion in global tax revenues – roughly the same as the entire Swiss federal budget. “For yea
Vindral Named Recipient of 2026 Technology & Engineering Emmy® Award9.9.2026 18:38:00 CEST | Press release
Swedish real-time video company recognised alongside the world's leading media companies for frame-accurate remote production technology Vindral, the Swedish company building future-ready technology for real-time audio and video, has been named a recipient of a 2026 Technology & Engineering Emmy® Award by the National Academy of Television Arts & Sciences (NATAS). Vindral is recognised in the category Web-Based Frame-Accurate Remote Monitoring Systems for Distributed Broadcast Production. The co-recipients in the category are SipRadius, NBCUniversal, Grass Valley, CBS Sports, Disney, Game Creek and Amazon. The awards will be presented on October 14 at the Television Academy's Saban Media Center in North Hollywood, California, where Vindral will be represented by CEO Daniel Alinder and Ian Jefferson. The Technology & Engineering Emmy® Award is one of the U.S. television industry's most prestigious recognitions of technical achievement, previously awarded to companies including Apple, So
Elliptic Intelligence Used by the USSS to Take Action Against Xinbi, the $30 Billion Criminal Marketplace and Money Laundering Operation9.9.2026 18:36:00 CEST | Press release
Elliptic, the global leader in risk intelligence for on-chain finance, today confirmed that it provided the intelligence used by the United States Secret Service in action taken today against the Xinbi marketplace. The U.S. Secret Service froze wallets belonging to the marketplace and its merchants, containing $52.8 million in cryptoassets linked to Xinbi marketplace. Elliptic provided the data and intelligence that no other provider could. The data was extracted from Elliptic’s Data Fabric Solutions into the USSS' systems, giving investigators the one hundred thousand-foot view, connecting on-chain and off-chain data to paint a full picture of illicit activity rather than a snapshot in one screen of data. Data Fabric provides access to the same blockchain data and intelligence set behind Elliptic’s solutions, and that Elliptic’s own intelligence team used to expose both Huione and Xinbi before anyone else. Since beginning operations in 2022, Xinbi Guarantee and its merchants have proc
HOF Capital Completes €1 Billion Acquisition of Porsche’s Stakes in Bugatti Rimac and Rimac Group9.9.2026 18:00:00 CEST | Press release
HOF Capital today announced the completion of its acquisition of Porsche’s equity interests in Bugatti Rimac and Rimac Group through an HOF-led consortium. The transaction, first announced in April 2026, closed following the satisfaction of all conditions, including regulatory clearances. Porsche’s combined interests were valued at approximately €1 billion. HOF Capital originated and led the transaction, assembling a consortium of institutional investors from the United States and Europe. Following completion of the transaction, HOF holds a 23.5% stake and becomes the largest shareholder in Rimac Group, which holds the 55% controlling interest in Bugatti Rimac. HOF and its consortium also acquired Porsche’s direct 45% interest in Bugatti Rimac. As part of the investment, HOF Capital holds three supervisory board seats across Rimac Group and Bugatti Rimac. Hisham Elhaddad, Co-Founder and Managing Partner of HOF Capital, has joined the Supervisory Boards of both Bugatti Rimac and Rimac G
The Rock-It Company Expands Dynamic Dox to Provide ATA Carnet Services Across the US and Canada9.9.2026 17:00:00 CEST | Press release
Expansion provides access and expert ATA Carnet services for customers across new regions The Rock-It Company announced today the expansion of Dynamic Dox, the industry-leading provider of ATA Carnets, to now service partners and projects based in the United States, Canada and beyond. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260909137375/en/ Following over a decade of expertise and leading service across the United Kingdom since 2014, Dynamic Dox will now provide new regions with dedicated document preparation for time-sensitive logistics projects, and urgent ATA Carnets for international shipments and critical business travel needs. The news of the expansion follows Dynamic Dox’s recent brand refresh, introducing an updated identity and connection to The Rock-It Company as Dynamic Dox By Rock-It. The expansion is led by Amanda Barlow, VP of Global ATA Carnets at The Rock-It Company, who has helped to drive the platfor
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