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| Parkinson's Disease Clinical Trials For posting and discussion of clinical trials related to Parkinson's Disease, and for the Parkinson Pipeline Project. All are welcome. |
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06-01-2008, 01:34 PM
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Magnate
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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
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06-01-2008, 08:07 PM
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Member
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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 below. In case anyone wonders.
Jaye 
Last edited by Jaye; 06-01-2008 at 08:10 PM. Reason: wrong board |
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