Kyowa decides to progress istradefylline into Phase III trials in Japan
Kyowa Hakko Kirin has decided to continue the domestic development of its proprietary Parkinson's disease drug KW-6002 (istradefylline) and move it forward with a Phase III trial in Japan, despite US regulators rejecting the compound last year due to lack of efficacy (Marketletter March 3, 2008). After receiving an action letter from the FDA, Kyowa decided to await the results of an ongoing Japanese Phase IIb study of the agent as adjunctive therapy to levodopa, and then determine a path forward.
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