Business Wire

KYOWA-KIRIN-CO.,-LTD.

Share
Kyowa Kirin Provides Update on Application for Marketing Authorisation of Istradefylline in Europe for the Treatment of ‘OFF’ Episodes in People Living with Parkinson’s

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

Link:

ClickThru

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

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

Belkin Achieves Qi2.2 Certification for Its Upcoming Products, Unlocking the Future of 25W Wireless Charging15.7.2025 19:06:00 CEST | Press release

With Qi2.2 certification, Belkin reinforces its commitment to quality, safety, and performance for the next generation of wireless charging Belkin, a leading consumer electronics brand for over 40 years, today announced it has received official Qi2.2 certification from the Wireless Power Consortium (WPC) for its upcoming products. As one of the first accessory brands to deliver Qi2.2-certified devices, Belkin is helping bring the next generation of wireless charging to market – enabling faster wireless charging speeds, broader compatibility, and improved performance for consumers. Belkin’s close partnership with the WPC since 2015 has been instrumental in bringing these advancements to consumers. As an early adopter and long-time contributor to WPC standards, Belkin was selected as one of a small group of trusted manufacturers to test and certify Qi2.2 products ahead of the broader industry rollout. All Belkin products undergo rigorous safety, quality, and performance testing. The comp

Cessna Grand Caravan EX to Feature New Executive Interior Options, Expanding Opportunities for Elevated Missions15.7.2025 18:05:00 CEST | Press release

The legendary Cessna Grand Caravan EX will now feature three new executive interior schemes for customers to select when designing their aircraft cabin. The Lunar, Obsidian and Saddle Sport interiors join the existing Canyon and Savanna schemes, providing a broader range of standard choices. The new interior options are available to customers starting this month and allow them to further tailor the interior of their aircraft based on their personal preference or mission. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250715021096/en/ Cessna Grand Caravan EX to feature new executive interior options, expanding opportunities for elevated missions (Photo Credit: Textron Aviation) The Cessna Grand Caravan EX is designed and manufactured by Textron Aviation Inc., a Textron Inc. (NYSE:TXT) company. Premium versions of each of the new interiors are also available, featuring quilted seat stitching and plush carpet, providing an elev

7 Million Tokens Sells Out in less than One Hour—$MBG Token Pre-Sale Shatters Expectations15.7.2025 17:27:00 CEST | Press release

MultiBank Group, the world’s largest and most regulated financial derivatives institution, has set a new benchmark in digital asset launches. The Group’s $MBG Token Pre-Sale sold out in less than one hour with all 7 million tokens fully subscribed across MultiBank.io and Uniswap. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250715055611/en/ The Group’s $MBG Token Pre-Sale sold out in less than one hour with all 7 million tokens fully subscribed across MultiBank.io and Uniswap. Commenting on the success of the Pre-Sale, Naser Taher, Founder and Chairman of MultiBank Group, said: “The sell-out of our initial $MBG Token offering in less than one hour is a decisive validation of our vision. In a market saturated with speculation, the response we received confirms that institutional-grade transparency, regulatory integrity, and asset-backed value are what investors are now demanding. $MBG is here for the long term, reflecting t

First Patient Enrolled in National Cancer Institute’s Vanguard Study Evaluating Guardant Health’s Shield Multi-Cancer Detection Test15.7.2025 17:01:00 CEST | Press release

Study addressing feasibility of using multi-cancer detection tests in future trials aims to enroll up to 24,000 participantsShield MCD reviewed by FDA as part of NCI’s investigational device exemption (IDE) Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, today announced that patient enrollment has begun in the National Cancer Institute (NCI)’s Vanguard Study to evaluate emerging multi-cancer detection (MCD) technology. Guardant’s Shield™ MCD test was selected for use in the four-year study, which aims to enroll up to 24,000 patients and evaluate the use of MCD tests—blood tests that can screen for several types of cancer simultaneously—in future randomized controlled trials. Guardant’s Shield MCD test was chosen for the study based on the overall performance of its Shield platform in detecting 10 cancer types, including lung, breast, colorectal, prostate, bladder, ovarian, pancreatic, esophageal, liver and gastric. The data were presented at the 2025 American

Deltatre Announces Acquisition of Endeavor Streaming to Create Digital and Streaming Platform Leader15.7.2025 16:15:00 CEST | Press release

Deltatre, a leading international provider of streaming, digital, data, and graphics solutions for the sports, media, and entertainment industries, today announced it has entered into a definitive agreement to acquire Endeavor Streaming from Endeavor Group Holdings, Inc. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250715833650/en/ Deltatre announces acquisition of Endeavor Streaming. In bringing together these complementary and proven digital and OTT providers, Deltatre is joining its advanced product suite – D3 VOLT, FORGE, AXIS, and DIVA, which delivers multi-functional digital experiences with integrated video – with Endeavor Streaming’s pure-play OTT product, VESPER. They will also unite their digital strategy, consulting, and direct-to-consumer growth marketing services. The combined business will be best equipped to deliver for sports, media, and entertainment clients through a compelling and comprehensive range of

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
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye