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
Photonics Innovators Worldwide Invited to Compete for SPIE Prism Awards1.7.2026 20:33:00 CEST | Press release
19th annual award honors exceptional new products transforming light-based technologies SPIE, the international society of optics and photonics, invites the optics and photonics community to apply for this year’s SPIE Prism Awards, which recognize outstanding new products making waves on the market. Honorees will be announced at the highly-anticipated award ceremony on 3 February 2027 at SPIE Photonics West in San Francisco, California. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260701642411/en/ SPIE Prism Awards honor exceptional new products transforming optics and photonics technologies. These awards, dubbed the “Oscars of Photonics,” provide scientists and engineers in the optics and photonics industry the opportunity to showcase their contributions to the field. Finalists and winners receive extensive print, web, and onsite promotion at SPIE Photonics West, which draws more than 22,000 researchers and industry leade
Around 500 Attend Sino-European ESG Conference in Germany1.7.2026 18:00:00 CEST | Press release
Around 500 government officials, business executives and academics from China and Europe gathered in the western German city of Mainz on Friday for the Third Sino-European Corporate ESG Best Practice Conference to discuss how deeper cooperation can support sustainable economic growth. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260701255421/en/ Group photo of selected attendees at the conference. Hosted by the Chinese Consulate General in Frankfurt and jointly organized with authorities from Germany and China, the conference brought together participants from China, Germany, France, Italy, the Netherlands, Denmark, Luxembourg and several other countries under the theme "From Vision to Practice: Empowering Sustainable Growth Through Collaboration." Francesco La Camera, Director-General of the International Renewable Energy Agency (IRENA), delivered a video address. Speaking at the opening ceremony, Huang Yiyang, Chinese Co
Sinopec Receives CSR Award at Sino-European ESG Conference in Germany1.7.2026 15:38:00 CEST | Press release
China Petroleum & Chemical Corp. (Sinopec) has received the Corporate Social Responsibility Best Practice Award at the 3rd Sino-European Corporate ESG Best Practice Conference in Mainz, Germany, for its case study on carbon footprint management and low-carbon development. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260701696760/en/ Huang Yiyang (L), Chinese Consul General in Frankfurt, presents the award to a representative of Sinopec. The conference jury said Sinopec has developed a carbon management framework centered on product carbon footprint management, covering the full product life cycle while aligning with both Chinese and European standards. It cited the company’s work with German chemical producer BASF to achieve mutual recognition of carbon footprint accounting methodologies as a milestone that could support greener cooperation across international industrial supply chains. According to the jury, Sinopec’s eff
Vercel and Mercedes-AMG PETRONAS Formula One Team Announce Multi-Year Strategic Partnership1.7.2026 15:30:00 CEST | Press release
The agentic infrastructure platform known for speed is joining forces with one of the world's fastest Formula One teams Today Vercel, the agentic infrastructure company, announced a new multi-year deal with the Mercedes-AMG PETRONAS Formula One Team. Starting with the British Grand Prix July 2 – 5 2026, Vercel branding will appear on the Mercedes-AMG PETRONAS Formula One Team race cars as the partnership begins its first chapter, before expanding significantly across the team ecosystem from 2027 onward. The partnership includes global branding rights, premium hospitality experiences, customer engagement, content creation, and technical collaborations, including plans to evolve the team’s digital platforms to Vercel. “Formula One is where every millisecond matters, every decision counts, and continuous innovation is fundamental to success. Vercel shares that same philosophy,” said Richard Sanders, Chief Commercial Officer, Mercedes-AMG PETRONAS Formula One Team. “The Vercel platform is
OXMIQ Raises $35 Million to Scale OxCore™ Architecture1.7.2026 15:15:00 CEST | Press release
OXMIQ Labs Inc., a unified GPU and AI architecture company founded by Raja Koduri, today closed its $35 million Series A financing, bringing the company’s total capital raised to $60 million. The funding will scale OxCore™, OXMIQ’s licensable GPU architecture that allows semiconductor companies and AI system builders to build custom AI silicon without a full chip program. The round was co-led by Fundomo and Samsung Catalyst Fund, with participation from MediaTek, AM Intelligence Labs, Pegatron Venture Capital, CDIB-TEN, Darwin Ventures, and Morgan Creek Digital, among other financial and strategic investors. OXMIQ’s expertise spans the full AI stack, from renewable power and data center infrastructure to silicon IP, electron-to-token machines (ETMs™), along with the software that runs AI factories and agents. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260701241910/en/ OXMIQ Funding raised to date of $60M after current $3
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