Kyowa Kirin Announces FDA Approval of NOURIANZTM (istradefylline) for Use in Parkinson’s Disease

Kyowa Kirin Announces FDA Approval of NOURIANZTM (istradefylline) for Use in Parkinson’s Disease

First and only Adenosine A2A receptor antagonist for use in Parkinson’s Disease in
the U.S.

Tokyo, Japan, August 28th, 2019 – Kyowa Kirin Co., Ltd.,
announces today that the U.S. Food and Drug Administration (FDA) has granted approval for
NOURIANZTM (istradefylline) for use as adjunctive treatment to levodopa/carbidopa in adult
patients with Parkinson’s disease (PD) experiencing “OFF” episodes.

“We are proud that NOURIANZ is now ready to help adult patients with Parkinson’s disease in
the US,” said Tomohiro Sudo, Head of Global Product Management Office of Kyowa Kirin, “We
believe that NOURIANZ could be an important contributor to improve treatment outcomes. We
will keep working to bring the product to patients globally.”

“Kyowa Kirin has a commitment to global health and well-being by creating new value through
the pursuit of advances in life sciences and technology particularly in oncology, nephrology,
immunology, and the central nervous system,” says Tom Stratford, President of Kyowa Kirin
USA Holdings, Inc.

“Today’s FDA approval of NOURIANZ is an important milestone and provides
US patients with a novel non-dopaminergic once-a-day oral treatment option to be used in
conjunction with levodopa/carbidopa for Parkinson’s disease.”

https://www.kyowakirin.com/media_center/news_releases/2019/pdf/e20190828_01.pdf