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., (Kyowa Kirin, TYO: 4151)
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.?
?Today?s approval is the culmination of decades of perseverance in exploring the science and
clinical effects of istradefylline and inhibition of adenosine A2A receptor signaling in people with
Parkinson?s disease,? said Jeffrey S. Humphrey, MD, Chief Development Officer of Kyowa Kirin
Pharmaceutical Development, Inc. ?In clinical studies, istradefylline, used as adjunctive
treatment to levodopa/carbidopa in adult patients with PD experiencing ?OFF? episodes, was
associated with a decrease in OFF Time and increase in ON Time without troublesome
dyskinesia. We are grateful for the FDA approval and for the many dedicated scientists and
patients whose participation in our research programs has resulted in a new treatment option
for Parkinson's disease.?
?Istradefylline is an Adenosine A2A receptor antagonist, and is 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.
?Based on data from four clinical studies, istradefylline taken as an adjunct to levodopa
significantly improved OFF time and demonstrated a well-tolerated safety profile. Istradefylline
represents an important new treatment option for patients with Parkinson's disease who
experience ?OFF? episodes.?
The FDA approval of NOURIANZ is based on findings from randomized, multi-center, doubleblind, placebo-controlled trials in patients with PD taking a stable dose of levodopa/carbidopa
with or without other PD medications.
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.
Please see NOURIANZ indication and Important Safety Information below.
Indication
NOURIANZ? (istradefylline) is an adenosine receptor antagonist indicated as adjunctive
treatment to levodopa/carbidopa in adult patients with Parkinson?s disease (PD) experiencing
?off? episodes.
Important Safety Information
Warnings and Precautions
Dyskinesia: NOURIANZ in combination with levodopa may cause dyskinesia or exacerbate preexisting dyskinesia. In clinical trials, 1% of patients treated with either NOURIANZ 20 mg or 40
mg discontinued treatment because of dyskinesia, compared to 0% for placebo.
Hallucinations / Psychotic Behavior: Because of the potential risk of exacerbating psychosis,
patients with a major psychotic disorder should not be treated with NOURIANZ. Consider
dosage reduction or discontinuation if a patient develops hallucinations or psychotic behaviors
while taking NOURIANZ.
Impulse Control / Compulsive Behaviors: Patients treated with NOURIANZ and one or more
medication(s) for the treatment of Parkinson?s disease (including levodopa) may experience
intense urges to gamble, increased sexual urges, intense urges to spend money, binge or
compulsive eating, and/or other intense urges, and the inability to control these urges. In
clinical trials, 1 patient treated with NOURIANZ 40 mg was reported to have impulse control
disorder, compared to no patient on NOURIANZ 20 mg or placebo.
Drug Interactions
The maximum recommended dosage in patients taking strong CYP3A4 inhibitors is 20 mg once
daily. Avoid use of NOURIANZ with strong CYP3A4 inducers.
Specific Populations
Pregnancy: Based on animal data, may cause fetal harm.
Hepatic impairment: The maximum recommended dosage of NOURIANZ in patients with
moderate hepatic impairment is 20 mg once daily. Avoid use in patients with severe hepatic
impairment.
Adverse Reactions
The most common adverse reactions with an incidence =5% and occurring more frequently
than with placebo were dyskinesia (15%, 17%, and 8%), dizziness (3%, 6%, and 4%),
constipation (5%, 6%, and 3%), nausea (4%, 6%, and 5%), hallucination (2%, 6%, and 3%),
and insomnia (1%, 6%, and 4%) for NOURIANZ 20 mg, 40 mg, and placebo, respectively.
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 NOURIANZ TM (istradefylline) tablet
NOURIANZ is an orally administered, selective adenosine A2A receptor antagonist approved in the
US for adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson?s disease (PD)
experiencing ?OFF? episodes. The product has been marketed in Japan under the brand name
NOURIAST? since May 30, 2013. In Japan, NOURIAST? is indicated for the improvement of the
?wearing-off? phenomenon in patients with Parkinson?s disease on levodopa-containing preparations.
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.
NOURIANZ? and NOURIAST? are trademarks of Kyowa Kirin Co., Ltd
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