EMA validates istradefylline application
Japanese mid-sized drugmaker Kyowa Kirin (TYO: 44151) today said its marketing authorization application (MAA) for istradefylline (KW-6002) as an adjunctive treatment to levodopa-based regimens in adult patients with Parkinson’s disease (PD) experiencing “OFF” time, has been validated by the European Medicines Agency (EMA) and is now under review.
This MAA is based on findings from randomized, multi-national, including European Union, US and Japan double-blind, placebo-controlled trials in patients with PD taking a stable dose of levodopa-based regimens with or without other PD medications.
Already launched in Japan and USA
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