TOKYO, February 28 /PRNewswire/ --
Kyowa Hakko Kogyo Co., Ltd. President: Dr. Yuzuru Matsuda announced that Kyowa Pharmaceutical, Inc. (New Jersey, United States), its wholly owned U.S. subsidiary, received on February 25, 2008 a Not approvable letter from the U.S. Food and Drug Administration (FDA) for istradefylline (KW-6002), its investigational drug for the treatment of Parkinson's disease.
In the not approvable letter FDA expressed concern if the efficacy findings support clinical utility of istradefylline (KW-6002). The FDA requested an overall summary of nonclinical mineralization findings. Additionally, the FDA asked for clinical pharmacology follow-up information as a Phase 4 commitment.