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
Vertex Presents New Data on ALYFTREK® at European Cystic Fibrosis Conference5.6.2026 18:00:00 CEST | Press release
- ALYFTREK Phase 3 data on children with cystic fibrosis ages 2 to 5 with vanzacaftor/tezacaftor/deutivacaftor-responsive genotypes including F/F and F/MF shows 65% reached sweat chloride levels of <30 mmol/L; Vertex on track to initiate global regulatory submissions in first half of 2026 - - Long-term 96-week interim analyses from two open-label extension studies demonstrate positive safety and efficacy profile of ALYFTREK in people with cystic fibrosis ages 6 and older -- Phase 3 data on TRIKAFTA® in children 1 to <2 years also presented; Vertex has initiated global regulatory submissions - Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced data demonstrating the potentially transformative impact of treating cystic fibrosis (CF) with ALYFTREK ® (vanzacaftor/tezacaftor/deutivacaftor) in children ages 2 to 5, as well as data from 96-week interim analyses of two open-label extension studies of ALYFTREK in children 6 to 11 years and people 12 years and older demonstrating
Owkin to Build AI Agents as Part of a Multi-Year K Pro Collaboration with Sanofi5.6.2026 13:00:00 CEST | Press release
Owkin, the agentic AI company pioneering Biological Artificial Superintelligence to transform drug discovery and development, today announced a multi-year collaboration with Sanofi to co-develop next-generation biopharma agents, to be backed by a five-year license for K Pro, Owkin’s AI Scientist. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260605704506/en/ K Pro, Owkin's AI scientist for biology, powered by multimodal patient data for smarter biopharma decision making. Owkin and Sanofi have collaborated since 2021 through a €90 million strategic partnership focused on target identification in oncology and patient subgrouping. The collaboration was later expanded to include drug positioning for Sanofi’s immunology pipeline. This new collaboration represents the next evolution in the partnership. During the five-year collaboration, Owkin will lead the end-to-end development of novel AI-driven biopharma agents purpose-built
DFNS Rebrands as the Core Banking Platform for Digital Assets5.6.2026 12:41:00 CEST | Press release
DFNS today announced a rebrand, marking its evolution from a wallet infrastructure to the first core banking platform for digital assets. The company is introducing a new logo, website, and market position as fintechs and institutions move their products and operations onchain. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260603859127/en/ Banks, fintechs, asset managers, trading firms, payment providers, market infrastructures, and clearing houses have stopped asking how to "add crypto." They're asking how to run financial products, controls, workflows, and client services on blockchain rails, with the reliability expected of core infrastructure. Some are going further still, exploring whether the blockchain can serve as the ledger itself, where an account is an onchain object rather than a row in a database. Where IBANs, virtual accounts, and blockchain wallets converge into one governed financial account. “DFNS was built
Compass Pathways Announces New Employee Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)5.6.2026 12:30:00 CEST | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that Compass granted equity awards under the Compass Pathways plc 2026 Inducement Plan to seventeen newly hired non-executive employees. The equity awards were granted on June 1, 2026 and consisted of options to purchase an aggregate of 157,000 shares and restricted share units or, in the case of employees in the United Kingdom nominal cost options, covering an aggregate of 74,700 shares. The options have an exercise price per share equal to $14.19, the closing price of the Company’s American Depositary Shares on the Nasdaq Global Select Market on the grant date, and will vest over a four-year period with 25% vesting on the first anniversary of the date of the grant and the remaining 75% vesting in equal monthly installments over the three-year period thereafter, subject to each employee’s continued employment. The restrict
Renewable Electricity, Soft Wheat Flour From Regenerative Agriculture, Initiatives to Support Local Communities: Barilla Shares These and Other Projects in “Stories of Sustainability.”5.6.2026 10:00:00 CEST | Press release
Barilla continues to advance its commitment to tastier products with less sugar and salt;An investment of 30 million euros in 2025 to quadruple photovoltaic capacity across plants, as part of a €168 million five-year plan focused on energy efficiency, renewable energy and sustainable water management.Barilla continues to expand regenerative agriculture practices across its global value chain, with over 816,000 tons of raw materials sourced through the Barilla Sustainable Farming program.4,000 tons of products donated worldwide and €2 million allocated to social causes in 2025, supporting communities across Barilla’s global footprint through food donations and social initiatives. A slimmer Tagliatelle pack that saves 150 tons of cardboard and cuts transport-related CO₂ emissions by 20%1; ready-made sauce jars made with around 65% recycled glass; the progressive scaling of regenerative agriculture practices across Barilla’s value chain and initiatives supporting inclusion and equal oppor
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