Kyowa Kirin Announces Marketing Authorisation Application for Istradefylline Validated by European Medicines Agency

Tokyo (ots/PRNewswire) - Kyowa Kirin Co., Ltd. (TSE: 4151) President and CEO:
Masashi Miyamoto, "Kyowa Kirin") today announces that its marketing
authorisation application (MAA) for istradefylline (KW-6002) as an adjunctive
treatment to levodopa-based regimens in adult patients with Parkinson's disease
(PD) experiencing "OFF" time, has been validated by the European Medicines
Agency (EMA) and is now under review.

This MAA is based on findings from randomised, multi-national, including EU, US
and Japan double-blind, placebo-controlled trials in patients with PD taking a
stable dose of levodopa-based regimens with or without other PD medications.

"Parkinson's disease is the fastest growing neurological disorder in the world
in terms of prevalence, disability and deaths1," said Abdul Mullick, President,
Kyowa Kirin International (Europe, Middle East and Africa (EMEA)). "There is
significant need for new treatments for this debilitating condition. We are very
excited about the possibility of bringing a new medicine to patients that works
in a different way from current therapies. We look forward to working with the
EMA during the review process."

"I welcome the news of this validation, enabling the EMA to begin the review
process," said Tomohiro Sudo, Head of Global Product Management Office, Kyowa
Kirin, "We are committed to providing this innovative medicine as a new
treatment option for Parkinson's disease patients who need more treatments to
improve their situation. We will keep making our best efforts to improve the
lives of patients in the European Union."

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.

About Kyowa Kirin

Kyowa Kirin commits to innovative drug discovery driven by state-of-the-art
technologies. Kyowa Kirin focuses on creating new values in the four therapeutic
areas: nephrology, oncology, immunology/allergy and neurology. Under the Kyowa
Kirin brand, the employees from 36 group companies across North America, Europe
and Asia/Oceania unite to champion the interests of patients and their
caregivers in discovering solutions wherever there are unmet medical needs.

You can learn more about the business of Kyowa Kirin at
https://www.kyowakirin.com

About istradefylline

Istradefylline is an orally administered, selective adenosine A2A receptor
antagonist. Istradefylline was approved in Japan (product name: NOURIAST®) in
March 2013 for improving the "wearing-off" phenomenon in patients with
Parkinson's disease on levodopa-containing preparations. Istradefylline was also
approved in the US (product name: NOURIANZTM) in August 2019 for use as
adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson's
disease experiencing "off" episodes.

About Parkinson's disease

Parkinson's disease is a progressive, neurodegenerative disease characterized by
motor symptoms such as tremors, rigidity, slow movement and postural
instability. It is thought to be caused by progressive degeneration associated
with decreased levels of dopamine in certain parts of the brain, i.e., the
substantia nigra and striatum.

1 [GBD 2016 Parkinson's Disease Collaborator Group. Lancet Neurol 2018; 17: 939
- 953]

Contact:

media@kyowakirin.com

Additional content: https://www.presseportal.de/pm/129059/4484237
OTS: Kyowa Kirin International PLC

Original-Content von: Kyowa Kirin International PLC, übermittelt durch news aktuell