Kyowa Kirin Announces FDA Acceptance of Istradefylline (KW-6002) New Drug Application Resubmission in the US

April 4, 2019 Off By BusinessWire

TOKYO–(BUSINESS WIRE)–Kyowa Hakko Kirin Co., Ltd. (TOKYO:4151, President and CEO: Masashi
Miyamoto, “Kyowa Kirin”) announced that the U.S. Food and Drug
Administration (FDA) has accepted for review the resubmitted New Drug
Application (NDA) for istradefylline (KW-6002), an investigational
selective adenosine A_2A receptor antagonist, for use as
adjunctive treatment to levodopa/carbidopa in adult patients with
Parkinson’s disease (PD) experiencing “OFF” episodes.

The target Prescription Drug User Fee Act (PDUFA) action date for a
decision by the FDA is in August 27, 2019. The submission is based on
findings from randomized, multi-center, double-blind, placebo-controlled
trials in patients with PD taking a stable dose of levodopa/carbidopa
with or without other PD medications.

“People living with Parkinson’s Disease have difficulty moving that
often worsens during ‘off’ periods, and there is a significant need for
new treatments”, said Jeffrey S. Humphrey, M.D., President and Chief
Medical Officer of Kyowa Kirin Pharmaceutical Development. “We are
excited by the possibility of bringing a new medicine to people living
with Parkinson’s Disease and look forward to working closely with FDA
during the review process.”

“Istradefylline, is an A_2A receptor antagonist, and if
approved by FDA, may provide a novel non-dopaminergic pharmacologic
approach to treating OFF episodes for people living with PD.” said Dr.
Stuart Isaacson, MD, Parkinson’s Disease and Movement Disorders Center
of Boca Raton, Florida.

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.kyowa-kirin.com.

About Istradefylline

Istradefylline is an orally administered, selective adenosine A_2A
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 in Japan under
the brand name NOURIAST^® since May 30, 2013. Istradefylline
has no approved indication in the US.

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 adenosine A_2A receptor

Adenosine is a neuromodulator that is widely distributed in the human
body and adenosine A_2A receptors are G protein-coupled
receptors. In the brain, adenosine A_2A 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.