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
Angelalign Technology Inc. (6699.HK) Applauds European Court Rejection of Patent Infringement Claim12.5.2026 19:39:00 CEST | Press release
Angelalign Technology Inc. (6699.HK) (“Angel”) (http://www.angelaligner.com) today said it was grateful that the Local Division Düsseldorf (Germany) of the Unified Patent Court rejected a request by Align Technology Inc. (ALGN) for Angel to cease and desist from using its A7 Premolar Extraction Solution. Angel denied that the A7 tooth movement protocol infringes any patents as alleged by Align Technology Inc. (ALGN). The court rejected Align’s request for Angel to preliminarily cease its use of the feature, a decision Angel applauded. “We respect the Düsseldorf Local Division’s ruling and will continue to make our case that Angel has not violated any valid patents,” said Dr. Arno Riße, Angel’s attorney at the Arnold Ruess law firm of Düsseldorf. “We are grateful that the court decided not to grant Align's request for preliminary measures. Angel takes intellectual property rights seriously and is careful not to infringe on legitimate patents.” “We categorically deny the allegations of i
Bharat Forge Signs Long-Term Contract with Embraer for Landing Gear Forgings12.5.2026 18:38:00 CEST | Press release
Bharat Forge Ltd. (BFL) (BSE: 500493, NSE: BHARATFORG), a global leader in advanced forging and precision engineering, today announced a long-term contract with Embraer for the manufacturing and supply of critical landing gear forgings. With this milestone, Bharat Forge becomes the first Indian supplier to join Embraer’s global aerospace supply chain for forged components. Under the agreement, Bharat Forge will supply high-integrity forged components for landing gear systems across Embraer’s commercial and Defence aircraft programs. This engagement establishes a strategic partnership anchored in advanced manufacturing capabilities, precision engineering, and proven expertise in delivering complex, safety-critical components for global aerospace platforms. The long-term contract reflects a shared commitment to quality, reliability, and sustained collaboration, and reinforces Embraer’s confidence in Bharat Forge’s ability to meet stringent global certification standards while consistentl
De' Longhi Group - 6.6% Growth at Constant Exchange Rates and Accelerated Net Profit: Solid Results Fully Support Guidance12.5.2026 18:37:00 CEST | Press release
The Group closed another quarter with robust organic growth, driven by the excellent expansion of the professional division, with turnover growing significantly and representing 18% of the Group's total for the period, and by the positive performance of the household The Board of Directors of De' Longhi S.p.A. approved the consolidated results 1for the first quarter of 2026: In the first quarter the Group achieved: revenues of € 777.7 million, up 3% (+6.6% at constant exchange rates); adjusted 2Ebitda of € 125.9 million, equal to 16.2% of revenues (15.4% in Q1-25); net profit (pertaining to the Group) of € 61.7 million, equal to 7.9% of revenues and up 7.5% compared to the previous year; net financial position at the end of March 2026 of € 720.5 million. CEO Fabio de' Longhi commented: “The start of 2026 was marked by solid revenue growth of 6.6% at constant exchange rates, continuing the excellent performance achieved in recent years. The professional division's strong expansion susta
Multi-Color Corporation Successfully Completes Comprehensive Financial Restructuring12.5.2026 18:09:00 CEST | Press release
Company Emerges Stronger, Well-Positioned to Execute Long-Term Strategy With Significantly Deleveraged Balance Sheet Multi-Color Corporation ("MCC" or the "Company") today announced the successful completion of the Company’s financial restructuring process and emergence from its prepackaged Chapter 11 process. The Company’s prepackaged restructuring reduced net debt by approximately $3.8 billion, reduced annualized cash interest expense by more than $330 million, and extended long-term debt maturities to 2033. More than 99% of voting stakeholders voted to accept MCC’s Plan of Reorganization. Upon emergence, MCC also received a significant $889 million new common and preferred equity investment from CD&R and a group of MCC’s existing secured lenders to support MCC’s long-term growth and investment. "Today marks a significant milestone for MCC, as well as our customers, teammates, and partners who have supported us throughout this process,” said Hassan Rmaile, President and Chief Executi
New Cessna Caravans to Boost USDA’s Fight Against Crop-Damaging Insects12.5.2026 17:00:00 CEST | Press release
Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company, today announced that the U.S. Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) has ordered three Cessna Caravan aircraft to support its sterile insect release program protecting citrus crops along the Rio Grande River in southern Texas. The new aircraft are expected to be delivered in 2027. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260512676348/en/ Mission-Ready: The Cessna Caravan joins USDA’s fight to protect Texas citrus from invasive pests APHIS will use the Caravans to carry and release sterile insects that help prevent the spread of destructive pests, including fruit flies. The environmentally friendly technique helps safeguard fruit-bearing trees, reduce crop damage and protect agricultural industries that rely on healthy harvests. “These aircraft will help APHIS reach remote areas and carry out their important mission o
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