Thread: Istradefylline (KW-6002)...FDA Not Approvable Letter
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Old 06-01-2008, 01:34 PM
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Default Istradefylline (KW-6002)...FDA Not Approvable Letter
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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