Posted by Michael Wonder on 07 Apr 2019
Kyowa Kirin announces FDA acceptance of istradefylline (KW-6002) new drug application resubmission in the US
4 April 2019 - Kyowa Hakko Kirin announced that the U.S. FDA has accepted for review the resubmitted new drug application for istradefylline (KW-6002), an investigational selective adenosine A 2A receptor antagonist, for use as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson’s disease (PD) experiencing “OFF” episodes.
The target Prescription Drug User Fee Act action date for a decision by the FDA is 27 August 2019.
The submission is based on findings from randomised, multi-center, double-blind, placebo-controlled trials in patients with PD taking a stable dose of levodopa/carbidopa with or without other PD medications.
