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
QI Tech and Ant International’s Bettr Partner to Expand Credit Access for E-Commerce Merchants and Consumers in Brazil26.6.2026 06:26:00 CEST | Press release
The strategic partnership drives financial inclusion, launching working capital programs for SME and Buy Now, Pay Later (BNPL) options on e-commerce platforms QI Tech, a leading financial services infrastructure provider, has joined forces with Bettr, a leading provider of inclusive and embedded financial services under Ant International, to expand credit solutions for e-commerce sellers and shoppers. The strategic partnership aligns with Brazil’s ongoing efforts to promote inclusive finance, launching targeted lending programs directly within digital marketplaces. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260622444217/en/ Consumers can select BNPL option at checkout, facilitated by Bettr In its initial phase, QI Tech is collaborating with Bettr to provide working capital loans for small and medium-sized e-commerce businesses, allowing them to expand inventory and scale operations effectively. This partnership also incl
Andersen Global tilføjer Andersen in Indonesia25.6.2026 22:21:00 CEST | Pressemeddelelse
Andersen Global styrker sin tilstedeværelse i Sydøstasien, da VDB Loi in Indonesia skifter navn til Andersen in Indonesia og dermed bliver det nyeste medlemsfirma, der tilslutter sig organisationen. Andersen in Indonesia yder skattemæssig og juridisk rådgivning til multinationale selskaber og udenlandske investorer, der er aktive på det indonesiske marked. Firmaet kombinerer årtiers markedserfaring med en praktisk tilgang, der fokuserer på at levere præcis og individuel rådgivning om komplekse regulatoriske og internationale forhold. "At blive en del af Andersen-brandet afspejler vores engagement i at give kunderne praktisk skattemæssig og juridisk rådgivning af høj kvalitet på grundlag af et bredere internationalt samarbejde," udtalte Tommy Hendharto Oetomo, administrerende partner for Andersen in Indonesia. "Kunder, der driver virksomhed i Indonesien, har brug for stadig mere koordineret støtte på tværs af landegrænser. At blive et medlemsfirma styrker vores evne til at levere den se
I-Pulse Signs Definitive Agreement with the U.S. Department of Commerce for $250 Million CHIPS R&D Award25.6.2026 20:53:00 CEST | Press release
■I-Pulse Will Develop Cutting-Edge Semiconductors that Support American Reindustrialization and National Security Goals■I-Pulse’s Technology Enables Cost-Competitive Development of America’s Vast Untapped Geothermal Energy Resources I-Pulse Co-founders Robert Friedland, CEO, and Laurent Frescaline, CTO, announced today a definitive agreement with the U.S. Department of Commerce’s CHIPS Research and Development Office for a $250 million award for the further development of I-Pulse’s proprietary semiconductor and pulsed power technology. “With today’s announced investment, the Trump administration is strengthening America’s capabilities and enhancing its national and energy security goals,” said Secretary of Commerce, Howard Lutnick. Co-founder Robert Friedland said: “We are excited to partner with the U.S. government to advance our unique, American technology suite to benefit our great nation. This award supports the development of world-leading critical components in the pulsed power t
Burjeel Holdings Prices First MENA Healthcare Sukuk Since 2018, 3.2x Oversubscribed25.6.2026 19:31:00 CEST | Press release
Burjeel Holdings, a leading super-specialty healthcare group in the GCC listed on the Abu Dhabi Securities Exchange, priced its inaugural USD 500 million Regulation S 5-year senior unsecured Sukuk offering due 2031 under its newly established USD 1.5 billion Senior Unsecured Sukuk Programme. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260625449702/en/ Burjeel Holdings’ inaugural Sukuk was priced at a 7.000 % profit rate and a yield of 7.125% (Photo: AETOSWire) The offering attracted significant demand from high-quality international and regional investors, with the orderbook peaking at USD 1.6 billion, representing 3.2x oversubscription. The strength of the orderbook enabled Burjeel to tighten pricing from initial price thoughts in the mid-7% area, with the Sukuk priced at a 7.000% profit rate and a yield of 7.125%, representing the lowest 5-year yield by a GCC-based private non-investment grade corporate issuer since 202
Fossil Fuels Are a Thing of the Past; The Future Is Renewable: The Smarter E Europe Concludes With a Clear Message25.6.2026 19:03:00 CEST | Press release
Packed halls, a vibrant atmosphere and a buzzing vibe – after three days, The smarter E Europe 2026, Europe’s largest alliance of exhibitions for the energy industry, has come to a successful close. The event held at Messe München offered a glimpse of a future-oriented energy world powered by renewables. A strong signal with a clear message went out to the world from the Bavarian capital: The future is renewable. Renewable energies can help ensure a reliable, secure and cost-effective energy supply around the clock, seven days a week. A total of 2,650 exhibitors from 52 countries – many of whom had expanded their booth space compared with the previous year – demonstrated how this can work. More than 66 percent of exhibitors were from outside of Germany. They presented innovative and market-ready products ranging from virtual power plants, smart grid and load control, smart charging solutions, storage technologies and PV hybrid systems to digital platforms transparently and flexibly.The
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