Kyowa receives not approvable letter from FDA for Parkinson's drug

29th February 2008
By Staff Writer
Kyowa Hakko Kogyo has reported that Kyowa Pharmaceutical, its wholly owned US subsidiary, has received a not approvable letter from the FDA for istradefylline, its investigational drug for the treatment of Parkinson's disease.

http://www.pharmaceutical-business-r...B-D8B4505320C5

I talked to the Principal Investigator's office at the site where I have been getting my istradefylline for the last 3-4 years. My phone message had been the first they'd heard of the FDA decision. I was told not to be disappointed yet, as it sounds like typical FDA procedure, and the drug may still be approved (eventually). I guess that means I may continue to get it, but I know a lot of you guys need it more than I do, so I want them to move it along. It reduces off time without increasing dyskinesia.
Still hopeful,
Jaye

No change in the situation at my testing center (that I know of) except that I now have to fill in a half-hourly report card for two days in the week prior to a review visit (every 4 months), showing ons, offs and dyskinesias. We did this 3-4 years ago, too, when I started participating in the trial.

distribution and /or production of KW6002- has been stopped in North America. it's share time - some are taking their goods elsewhere rather than continue trying with the FDA. Solvay has taken years to get over here even though the treatment is available outside the US. But on the other hand, do i trust any other country, other than our allies, to have completed research on the product safely and with evidence of efficacy? Does it [non-approval] have to do with the evidence[some] coming from participant diaries? People will go to great lengths sometimes, like the disgraced Korean - i think we'd all agree that was pretty far.

so who do you believe? DJM1 doesn't have to guess or choose who to believe. She had sugery to remain qualified and posted her distress. We can't let her treatment disappear without the details.

So let's post what we can and find out. Again, this is not a test. This is a real storm alert.

As Arnold says. 'I'll be back.'

paula

I was supposed to have heard last week from the nurse practitioner at the testing center, as I always do in the intervals between visits, so on Monday I called her. She responded on Tuesday. She said she'd been "dragging her feet" about calling me because she hated to give me the news. Yup, Kyowa pulled out of the whole laborious wrangle with the FDA [MY phrasing, not hers]. I have to stop taking istradefylline in July. I'll be away for a while then, so my appointment is July 30. I expect I'll be like the undead for a while after that, or maybe forever. That does it! I'm taking up yoga.

Jaye

I am a new member researching on behalf of my father. I am saddened to watch my father's life change drastically when he was forced to stop taking KW-6002. It had done wonders for him. I am willing to go anywhere to purchase the drug, does anyone know where or how to get medication when a clinical trial ends. I am new to this and live thousands of miles from my parents and cannot talk to the clinical trial doctors in person, so I thought I would post here as I am sure someone out there knows. Thank you for any information you may have.

Istadefylline worked for me. In fact, it worked really well for me. For three years (I was also on an earlier Istradefylline trial), I had an overall better qualilty of life that I attribute to the drug. Because of travel insurance implications, I had to come off this medication immediately after Kyowa pulled the drug. I have now been off the drug for about 9 weeks. I am more rigid, slower, more fatiqued and have less stamina. Most of you here will know that those symptoms also impact "on" and "off" time, sleep, exercise, energy, not to mention emotional stress. I guess the bottom line is that I felt good on this drug and now I do not. I was very functional on this drug and now I am not. I hear that it is the same for others. Most of the study site reports that I was able to read indicated that efficacy result were not stunning, but were significant. That is all I care about and I really resent that the drug company and the FDA could not work together to find a less drastic solution than the one that has resulted. The political and financial dealings between phamaceutical companies and government agencies do not really interest me, but I have a feeling that someone here took all their toys and went home early. r

I'm a new member. How would I get this drug for my dad? Also, does anyone know if it helps possible cognitive dysfunction in Parkinson's. I think my dad is ikat as far as that goes, but out of curiousity...

So I was doing research on the KW-6002 clinical trial and ran across NeuroTalk. I'm hoping someone will have some advice for me. My mom was diagnosed with Parkinson's 7 years ago and later put on this clinical trial. Come to find out this year she was misdiagnosed! I am unable to find anyone from this Kyowa Pharmaceutical co...as they are in Japan. I see that it wasn't approved (sorry) but I'm wondering why, what effect could this have on my mom!

Hello Jaye...I was wondering what sort of side effects you experienced from taking istradefylline and also if the drug really helped you?