New Drug Application Resubmitted for Istradefylline for Parkinson’s Disease OFF Periods

A new drug application has been resubmitted to the Food and Drug Administration (FDA) for istradefylline (KW-6002; Kyowa Hakko Kirin Co., Ltd., Tokyo, Japan). Istradefylline has been investigated as an adjunctive treatment to levodopa/carbidopa for Parkinson’s disease OFF symptoms.

Istradefylline is an investigational, selective adenosine A2A receptor antagonist approved in Japan for the adjunctive treatment of the wearing-off phenomenon but has no approved indication in the US. “Istradefylline is an A2A receptor antagonist, and if approved by FDA, may provide a novel, nondopaminergic, pharmacologic approach to treating ‘off’ episodes for people living with PD,” said Stuart Isaacson, MD, director, Parkinson’s Disease and Movement Disorders Center of Boca Raton.