> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Kyowa Parkinson’s Therapy NDA Resubmitted
- URL: https://www.fdaweb.com/kyowa-parkinsons-therapy-nda-resubmitted/
- Published: 2019-04-04T12:00:00.000Z
- Updated: 2026-09-15T01:18:30.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143790

FDA has accepted for review a Kyowa Hakko Kirin resubmitted NDA for KW-6002 (istradefylline), an investigational selective adenosine A2A receptor antagonist for use as adjunctive treatment to levodopa/carbidopa in adult patients with Parkinson’s disease experiencing “off” episodes. The agency 2/2018 rejected the submission, citing concern about whether "efficacy findings support clinical utility of istradefylline," according to the company. The agency also requested an overall summary of nonclinical mineralization findings. Additionally, it asked for clinical pharmacology follow-up information. FDA has given the NDA a user fee review action target of 8/27.