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
Andersen Consulting styrker sit cybersikkerhedstilbud gennem samarbejde med Trillium Information Security Systems21.3.2026 02:16:00 CET | Pressemeddelelse
Andersen Consulting udbygger sine kompetencer inden for teknologi og risikostyring gennem en samarbejdsaftale med Trillium Information Security Systems (TISS), et cybersikkerhedsfirma. Med en tilstedeværelse i Canada og Pakistan leverer TISS omfattende cybersikkerhedsløsninger til organisationer inden for finans, telekommunikation og den offentlige sektor. Virksomhedens team tilbyder et bredt udvalg af ydelser, herunder sikkerhedsvurderinger, managed security operations, red team-tjenester, digital efterforskning og hændelsesrespons samt GRC-rådgivning. Med næsten to årtiers erfaring leverer TISS adaptive, efterretningsdrevne forsvarsmekanismer, der hjælper kunder med at forudse og reagere på cybertrusler, der er i konstant udvikling. "Hos TISS arbejder vi på at skabe et mere sikkert digitalt miljø ved at give organisationer mulighed for at operere sikkert og med selvtillid," udtalte Mahir Mohsin Sheikh, administrerende direktør for TISS. "Vores samarbejde med Andersen Consulting giver
Andersen Consulting udvider sin teknologiplatform i Frankrig20.3.2026 17:28:00 CET | Pressemeddelelse
Andersen Consulting udvider sit udbud inden for digital transformation med en samarbejdsaftale med Teolia Consulting, et fransk firma, der specialiserer sig i projekt- og produktstyring, cloud-platformsudvikling, datatransformation samt implementering og brug af Atlassian-pakken. Teolia Consulting blev grundlagt i 2014 og hjælper organisationer med at opnå digital performance, fra agile metoder til løsninger, der reducerer lanceringstiden. Virksomhedens ekspertise består i at levere integrerede strategier, der bringer teknologi og organisatorisk forandring i overensstemmelse. Virksomheden arbejder på tværs af brancher, herunder inden for bank- og finanssektoren, forsikring, mode og detailhandel, og hjælper kunder med at få større robusthed og accelerere deres digitale modenhed. "Hos Teolia Consulting mener vi, at ægte transformation opstår, når teknologi og mennesker udvikler sig sammen," sagde Lucienne Jacquet, der er administrerende partner i Teolia. "Ved at samarbejde med Andersen C
Incyte to Highlight Late-Breaking Hidradenitis Suppurativa Data at the 2026 American Academy of Dermatology (AAD) Annual Meeting20.3.2026 15:00:00 CET | Press release
- New, late-breaking 54-week data for povorcitinib in hidradenitis suppurativa (STOP-HS1 & STOP-HS2) to be highlighted - Featured abstracts for ruxolitinib cream (Opzelura®) and povorcitinib include multiple ePosters in atopic dermatitis, hidradenitis suppurativa and vitiligo Incyte (Nasdaq:INCY) today announced that data from key programs in its Inflammation and Autoimmunity (IAI) franchise will be presented at the 2026 American Academy of Dermatology (AAD) Annual Meeting, to be held March 27 – 31, 2026, in Denver. “At AAD 2026, we are presenting late‑breaking 54-week results from the Phase 3 STOP‑HS program evaluating povorcitinib in hidradenitis suppurativa (HS),” said Jim Lee, M.D., Ph.D., Group Vice President, Inflammation and Autoimmunity, Incyte. “These data provide longer term evidence of the safety and efficacy of povorcitinib in HS patients and further strengthen the significant growth potential of our Inflammation and Autoimmunity franchise.” Details on key data presentation
MUSASHI JAPAN by TAIMATSU Launches “Road to Shogun” – A Journey Through Craftsmanship and Discovery20.3.2026 13:58:00 CET | Press release
Musashi Japan by TAIMATSU Co., Ltd., a contemporary Japanese knife brand rooted in the spirit of craftsmanship and cultural harmony, has announced its newest experiential campaign: “Road to Shogun.” This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260320887471/en/ Designed as the brand’s most ambitious customer journey to date, the campaign invites visitors to explore participating Musashi Japan stores while discovering the traditions, culture and craftsmanship that inspire the brand. Inspired by the journey towards mastery, the experience encourages participants to progress through a series of ranks whilst visiting stores and unlocking rewards that celebrate elements of everyday Japanese culture. At Musashi Japan, craftsmanship is not only about the final product, but also about the path taken to achieve mastery. The Road to Shogun reflects this philosophy by guiding customers through a journey that mirrors the dedication, cu
Futur Delivers Strong Growth and Record Profit in 202520.3.2026 12:05:00 CET | Press release
In 2025, Futur added 21,000 new customers and the inflows amounted to 34 billion kronor. At the end of the year, the total savings capital was 252 billion kronor, an increase of 7% from the previous year and a new record level. "2025 was a record year for Futur. In a market characterized by sharp market fluctuations, Futur continued to invest, grow and deliver strong results. Behind this record performance is stable customer growth, strong inflows and cost discipline. Our close cooperation with over 60 partners gives customers the freedom to choose the asset management and advisory services that best suit them. The strategy of letting the customer choose is appreciated, which is reflected in us welcoming more than 21,000 new customers during the year", says Torgny Johansson, CEO of Futur. "We are optimistic about the future. Futur has great opportunities to continue growing in the coming years by developing innovative and efficient services for savings and pensions. I am proud of how a
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