Nouriast
Publisher: Datamonitor Healthcare
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Drug Overview
Nouriast (istradefylline; Kyowa Hakko Kirin) is the first, and so far, the only adenosine A2a receptor antagonist to be approved for the treatment of Parkinson’s disease. It acts to decrease overactivity of the indirect pathway of the motor circuit that is present in Parkinson’s disease patients with low dopamine levels. Adenosine A2a receptor antagonists modulate the production of dopamine, glutamine, and serotonin in specific regions of the brain. This mechanism of action has been shown to significantly modulate the “off” time without increasing dyskinesia in patients with Parkinson’s disease.
Although Nouriast was initially developed for the US, the US Food and Drug Administration (FDA) issued an initial non-approvable letter to Kyowa Hakko Kirin in February 2008. After resuming clinical development, Nouriast’s first approval came in Kyowa Hakko Kirin’s domestic market, Japan, in March 2013. Kyowa Hakko Kirin has since conducted further clinical studies that will support an intended resubmission to the FDA in 2018.
CONTENTS
4 OVERVIEW
4 Drug Overview
5 Product Profiles
5 Nouriast : Parkinson’s disease
LIST OF FIGURES
9 Figure 1: Nouriast for Parkinson’s disease – SWOT analysis
10 Figure 2: Datamonitor Healthcare’s drug assessment summary of Nouriast for Parkinson’s disease
11 Figure 3: Datamonitor Healthcare’s drug assessment summary of Nouriast for Parkinson’s disease
13 Figure 4: Nouriast sales for Parkinson’s disease in Japan, 2016–25
LIST OF TABLES
6 Table 1: Nouriast drug profile
7 Table 2: Nouriast pivotal trial data in Parkinson’s disease
13 Table 3: Nouriast sales for Parkinson’s disease in Japan ($m), 2016–25
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