Kyowa Kirin announces marketing authorisation application for istradefylline validated by European Medicines Agency

Kyowa Kirin

6 January 2020 - Kyowa Kirin today announces that its marketing authorisation application for istradefylline (KW-6002) as an adjunctive treatment to levodopa-based regimens in adult patients with Parkinson’s disease experiencing “OFF” time, has been validated by the EMA and is now under review.

This application is based on findings from randomised, multi-national, including EU, US and Japan double- blind, placebo-controlled trials in patients with Parkinson's disease (PD) taking a stable dose of levodopa-based regimens with or without other PD medications.

Read Kyowa Hakko Kirin press release

Michael Wonder

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Michael Wonder

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Medicine , Europe , Dossier