News Release

Kyowa Kirin Announces Refiling of Istradefylline (KW-6002)'s New Drug Application in the US

March 1, 2019

Tokyo, Japan, March 1, 2019 --- Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and COO: Masashi Miyamoto, "Kyowa Kirin") announced it has resubmitted a New Drug Application to the Food and Drug Administration (FDA) for Istradefylline (KW-6002), an investigational selective adenosine A2A receptor antagonist, for use as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson's disease experiencing "OFF" episodes.

"Parkinson's disease remains an area with unmet medical needs," said Jeffrey S. Humphrey, MD, President and Chief Medical Officer of Kyowa Kirin Pharmaceutical Development. "We look forward to working closely with FDA to assess istradefylline as a potential new treatment for patients with Parkinson's disease."

The Kyowa Hakko 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 Hakko Kirin Co., Ltd. is a research-based life sciences company, with special strengths in biotechnologies. In the core therapeutic areas of oncology, nephrology and immunology/allergy, Kyowa Hakko Kirin leverages leading-edge biotechnologies centered on antibody technologies, to continually discover innovative new drugs and to develop and market those drugs world-wide. In this way, the company is working to realize its vision of becoming a Japan-based global specialty pharmaceutical company that contributes to the health and wellbeing of people around the world.
You can learn more about the business at: www.kyowakirin.comNew window opens.
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.
About Istradefylline
Istradefylline is an orally, administered selective adenosine A2A receptor antagonist indicated in Japan for the improvement of the "wearing-off" phenomenon in patients with Parkinson's disease on levodopa-containing preparations and has been marketed under the brand name NOURIAST® since May 30, 2013. Istradefylline has no approved indication in the US.
About adenosine A2A receptor
Adenosine is a neuromodulator that is widely distributed in the human body and adenosine A2A receptors are G protein-coupled receptors. In the brain, adenosine A2A receptors are found in the basal ganglia, where degeneration or abnormality is noted in Parkinson's disease. The basal ganglia are known to play an important role in motor control.
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