KYOWA-KIRIN-CO.,-LTD.
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
Enginzyme and AGC Create Scalable Process for Key mRNA Ingredient12.1.2026 06:00:00 CET | Press release
At the mRNA Health conference in Berlin, enginzyme and AGC Inc. presented a scalable process to produce a key mRNA vaccine and therapy ingredient, N1-methylpseudouridine-5'-triphosphate (m¹ΨTP). The rapid growth of mRNA-based vaccines and therapeutics has driven significant demand for modified nucleotides like m¹ΨTP, which enhances mRNA stability and expression, while reducing immunogenicity. Enginzyme is a deep-tech company delivering optimized biomanufacturing solutions through cell-free enzyme engineering technology. AGC Inc. is a leading global player in fields spanning from architectural glass to chemicals and life science. AGC Inc. provides services in a wide range of life science fields, from synthetic pharmaceuticals and agrochemicals, to biopharmaceuticals and leading-edge cell and gene therapies, as well as messenger RNAs. The presentation in November detailed the latest collaboration between the companies, with a focus on the biomanufacturing of nucleotides for mRNA therapy,
Ant International Partners with Google’s Universal Commerce Protocol to Expand AI Capabilities12.1.2026 02:15:00 CET | Press release
Ant International, a leading global payment, digitisation, and financial technology provider, is collaborating on the launch of Google’s Universal Commerce Protocol (UCP), a new open standard for agentic commerce that works across the entire shopping journey — from discovery and buying to post-purchase support. UCP establishes a common language for agents and systems to operate together across consumer surfaces, businesses, and payment providers to enable commerce. So instead of requiring unique connections for every individual agent, UCP enables all agents to interact easily. UCP is built to work across verticals and is compatible with existing industry protocols like Agent2Agent (A2A), Agent Payments Protocol (AP2), and Model Context Protocol (MCP). “For agentic commerce to scale, it’s critical for the industry to align on a common set of standards. We are proud to have Ant International endorse the Universal Commerce Protocol as the foundation for that future,” said Ashish Gupta, VP
Torq Secures $140M Series D at $1.2B Valuation to Lead the AI SOC and Agentic AI Era11.1.2026 17:59:00 CET | Press release
Fueled by Massive Customer Adoption of AI Agents, Torq Scales the World’s First True AI SOC Platform and Accelerates Expansion into the U.S. Federal Market Torq, the established Agentic AI security operations pioneer, today announced it has closed a massive $140 million Series D funding round, propelling its valuation to $1.2 billion and total funding to $332M. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260112510774/en/ Led by Merlin Ventures—a leading cybersecurity fund renowned for its deep access to the U.S. commercial and Public Sector markets—with participation from all existing investors, including Evolution Equity Partners, Notable Capital, Bessemer Venture Partners, Insight Ventures Partners, and Greenfield Partners, this capital injection is a definitive investment in the future of security. Torq is driving the industry’s critical shift: the complete transformation of the Security Operations Center (SOC) through
Andersen udvider sine kompetencer med tilføjelsen af Scimitar9.1.2026 21:44:00 CET | Pressemeddelelse
Andersen Consulting har indgået en samarbejdsaftale med Scimitar, der er et firma med fokus på at accelerere innovation i biovidenskabsbranchen. Scimitar, der har hovedkvarter i USA, et førende konsulenthus inden for strategieksekvering for biovidenskabsbranchen. Virksomheden er specialiseret i design af driftsmodeller, digital transformation og organisatorisk forandring. Scimitar samarbejder med medicinal- og biotech-virksomheder om at accelerere innovation, styrke den driftsmæssige eksekvering og sikre compliance gennem hele produkters livscyklus. Deres praktiske og samarbejdsorienterede tilgang sikrer løsninger, der ikke blot er formålstjenlige, men også skalerbare. "Virksomheder inden for biovidenskabsbranchen befinder sig i en tid med hurtige videnskabelige fremskridt, stigende regulatorisk kompleksitet og et voksende behov for operationel agilitet, samtidig med at de holdes op mod de højeste standarder for patientsikkerhed og dataintegritet," udtaler Ramy Khalil, CEO i Scimitar.
Biocytogen and Acepodia Expand Collaboration Through Option-based Evaluation Framework for First-in-Class Bispecific and Dual-Payload ADCs (BsAD2C)9.1.2026 13:00:00 CET | Press release
Expanded collaboration builds on Acepodia and Biocytogen’s recent co-development efforts to evaluate selected bispecific antibody and dual-payload ADC programs Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, SSE: 688796; HKEX: 02315) and Acepodia (6976:TT), today announced that the companies have entered into an option and license agreement designed to enable the structured evaluation of bispecific antibody-drug conjugate (BsADC) programs to further advance the development of dual-payload bispecific antibody-drug conjugates (BsAD2Cs). The agreement grants Acepodia an option to obtain an exclusive worldwide license from Biocytogen for two BsADC programs. Under the terms of the agreement, Biocytogen is eligible to receive an upfront option fee and, upon Acepodia’s exercise of the option, additional payments including option exercise fees, development, regulatory, and commercial milestone payments, as well as royalties on future product sales. The financial terms of the agreem
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