Kyowa Hakko Receives Not Approvable Letter from FDA for Istradefylline (KW-6002)

February 28, 2008
http://www.kyowa.co.jp/eng/netext/er080228_01.htm

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 (local time) 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). FDA requested an overall summary of nonclinical mineralization findings. Additionally, FDA asked for clinical pharmacology follow-up information as a Phase 4 commitment.

After closely examining the FDA's response, Kyowa Hakko will work closely with FDA and conduct a comprehensive discussion to determine a path forward for istradefylline (KW-6002).

Istradefylline (KW-6002) has a novel mechanism...READ full press release

Thanks Carolyn, I was in Phase 1 to 3 of this drug as part of a Clinical Drug Trial. I got the boot for Phase 4 for going off Mirapex on my own volition.

Thanks for posting this, Carolyn. I just happened to notice, since I'm in the study, that this is the same FDA letter that was referred to in the similar thread on the "Parkinson's Disease Clinical Trials" board, linked above the thread topics for this board. In case anyone wonders.

Jaye