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
Network X Awards 2026 Finalists Announced, Spotlighting Telecom Innovation and Industry Excellence5.8.2026 08:00:00 CEST | Press release
Defining innovators recognised across AI, fibre, mobile networks, Wi-Fi and data centre infrastructure in Vienna Network X, the global event series bringing together the international fixed-line, transport and mobile telecom communities, today announced finalists for the fifth annual 2026 Network X Awards, recognising the companies, technologies and projects driving innovation across the global telecommunications industry. Celebrating excellence across 21 solution provider and operator categories, winners will be announced on 14 October during an awards ceremony at the Museum of Applied Arts (MAK) in Vienna. “The Network X Awards recognise the technologies, solutions and industry leaders actively shaping the next generation of global connectivity,” said Chris Lycett, Event Director, Network X. “With more companies entering than ever before, this year was the most competitive process to date. The finalists reflect an industry undergoing rapid transformation, from AI-driven network opera
European AI Startups Grab Record 55% of VC Capital as H1 Funding Reaches $23B5.8.2026 00:01:00 CEST | Press release
New HumanX/Crunchbase data shows a 130% YoY surge, though 73% of capital concentrated in just 38 breakout deals European AI startups raised a record-breaking $23 billion in the first half of 2026, a 130% year-over-year surge that captured 55% of all venture capital in the region, according to the 2026 European AI Economy Report released today by HumanX and Crunchbase. Up from $10 billion in H1 2025, the historic funding total signals that Europe is rapidly asserting itself as a primary engine of global AI innovation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260804090835/en/ "If the AI story was supposed to be a two-horse race, Europe didn't get the memo," said Stefan Weitz, Co-Founder and CEO of HumanX. "$23 billion is flowing straight into the industries Europe already leads: robotics, healthcare, advanced manufacturing, defense. This is a continent betting on its own strengths." Capital concentrates in a small cohort
IFF Reports Second Quarter 2026 Results; Announces Use of Proceeds Plan for Food Ingredients Divestiture4.8.2026 22:15:00 CEST | Press release
Delivered Strong Sales, Profit and Cash Flow Performance in Second Quarter 2026Provides Full Year 2026 Financial Guidance on a Continuing Operations BasisAnnounces Enhanced $2.5B Share Repurchase Authorization; Including $500M Accelerated Share Repurchase in the second half of 2026 IFF (NYSE: IFF) reported financial results for the second quarter ended June 30, 2026. Results are presented on a continuing operations basis, excluding the Food Ingredients business and other minor perimeter adjustments (the “Food Ingredients disposal group”), and the Soy Crush, Concentrates, and Lecithin businesses (the “SCL disposal group”). The Food Ingredients disposal group and the SCL disposal group are reported as discontinued operations. Management Commentary “IFF delivered a strong first half of 2026 on a continuing operations basis,” said Erik Fyrwald, CEO of IFF. “Performance was driven by volume growth, disciplined margin execution and robust free cash flow generation. These results reflect the
Crimson Moon Releasing September 1 for $19.99 USD, Offering This Fall’s Best Value for a Hellish Action RPG, Solo or With a Friend4.8.2026 19:00:00 CEST | Press release
The Blood-Soaked Action-Adventure RPG from ProbablyMonsters Will Feature Original Music from Metal Musicians Behind HEALTH, Ice Nine Kills, Oni, and Periphery ProbablyMonsters, an independent video game company focused on building original IP, today announced that Crimson Moon will release September 1, 2026, on PC via Steam and the Epic Games Store, PlayStation 5, and Xbox Series X|S for $19.99 USD, offering a focused game that delivers high-quality visuals and gameplay at an accessible price point. The company also revealed that famous metal musicians HEALTH, Jared Dines, Misha Mansoor, and Ricky Armellino will be composing original songs for the game’s boss encounters. The details were confirmed in a newly-released gameplay trailer, which also announced a Deluxe Edition of Crimson Moon that will cost $29.99 USD on all platforms, offering players access to the Ceremonial Armor Set and the Axe of the Gods weapon cosmetic, along with an upcoming expansion for Crimson Moon that will be r
Frontgrade Expands Executive Team as Demand Grows for Mission-Ready Space and Defense Technologies4.8.2026 17:48:00 CEST | Press release
Leaders from Raytheon, Lockheed Martin, Honeywell, Marotta Controls, and MACOM join to strengthen operational excellence, accelerate product readiness, and deepen customer engagement Frontgrade Technologies Inc. (“Frontgrade”), a leading provider of mission-critical electronics and subsystems, today announced the expansion of its executive leadership team as it continues to invest in the capabilities for the next generation of space, defense, and intelligence missions. Spanning finance, information technology, operations, reputation, go-to-market, and product leadership, the appointments reinforce Frontgrade's commitment to accelerating innovation and helping customers navigate an increasingly complex environment. The six appointments include: Andrew Matsuyama, Chief Financial Officer, brings more than 30 years of finance and business leadership experience during periods of growth and transformation in industrial and technology driven organizations. Most recently he served as CFO for H
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