Nouriast
 

I simply cannot understand why burocracy is always stopping progress :mad:

Nouriast
http://kyowa-kirin.com/news_releases...130529_01.html
is being sold in Japan since May '13 but not available elsewhere because further testing is needed for approval :confused:

I don´t think that Japan's approval procedures are less strict than any other countries' procedures. Shouldn't there be an internationally accepted/agreed procedure for the approval of new treatments so that we, the patients, can benefit as soon as possible from new advances in medicine?

Does anybody know how to get this in Europe?

Sorry for the rant, but you know, sometimes...

Non-approvable
 

The FDA here in the USA declared this non-approvable back in 2008. Apparently it only works on Japanese!

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).

Thanks for the information.

I've searched and found the japanese agency report (PMDA):
http://www.pmda.go.jp/english/servic..._mar2013_e.pdf

Mineralization was observed on animals but at very high dosis (30mg/kg/day and up). After reading the report it doesn't seem to me more dangerous than a cup of coffee or an aspirin. I recently read that aspirin would not be approved in the US with current regulation. I think that sometimes regulation is less about the patients and more about avoiding lawsuits.