FAQ/Help |
Calendar |
Search |
Today's Posts |
06-01-2008, 01:33 PM | #1 | |||
|
||||
Magnate
|
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
__________________
You're alive. Do something. The directive in life, the moral imperative was so uncomplicated. It could be expressed in single words, not complete sentences. It sounded like this: Look. Listen. Choose. Act. ~~Barbara Hall I long to accomplish a great and noble tasks, but it is my chief duty to accomplish humble tasks as though they were great and noble. The world is moved along, not only by the mighty shoves of its heroes, but also by the aggregate of the tiny pushes of each honest worker. ~~Helen Keller |
|||
Reply With Quote |
06-01-2008, 05:31 PM | #2 | |||
|
||||
Member
|
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.
__________________
"Trust your nervous system" - Timothy Leary |
|||
Reply With Quote |
06-01-2008, 08:11 PM | #3 | ||
|
|||
Member
|
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 |
||
Reply With Quote |
Reply |
|
|
Similar Threads | ||||
Thread | Forum | |||
istradefylline (KW-6002) not approved | Parkinson's Disease Clinical Trials | |||
U.S. FDA Issues Approvable Letter for Requip XL Extended Release Tablets | Parkinson's Disease | |||
A Letter from Iraq | Multiple Sclerosis |