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tomleewa

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Has anyone called FDA yet? Why it takes a year to approve this medicine? I will try to call FDA in the morning.
 

Lkaibel

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The time frames for FDA approval are insane - and have been a topic of discussion and criticism for years.
 

affected

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AKNate, thanks for the update. How long does he have to be there for this rx? Does he have to go back again for more?
 

AKNate

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Hey Tillie, he's there until end of May! He does it daily except for public holidays & Sunday. I'm going to be there with him for 3 weeks in May.

He'll need to continuously be on this med now & that's my latest problem - trying to find a doctor to prescribe it in AU & trying to find a place to administer it with or without script. If we successfully can bring the meds here, we will only need to go back for a 3 month supply or holiday ;)
 

affected

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Thanks. Another question as I'm really curious about this - will have to continue daily infusions forever?

Have you talked with Dominic Rowe about this? I'd be very curious to know his thoughts on it too! (Prof Rowe is Australia's equiv of Dr B with just a wild bow tie collection instead of total wardrobe :lol:)
 

AKNate

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Yes Tillie, i'd say he would need to do it daily for life. It slows progression by 25% and with Riluzole being another 10% - 35% slow down rate is pretty good compared to what we currently have out there! It's just a bit hard on his arms/veins :( I'm hoping they release the pill form soon.. I know it's about to start Phase 2 soon.

We didn't end up going before my husband left! I really want to see him but spoke to one of his patients on FB randomly and they told me he didn't think Edavarone would be worth it - not sure why he said that, maybe it was for this particular patient? So now i'm nervous, i don't want to hear someone say not to take this medicine :(
 

bear1973

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could anyone post or pm me with a link of where to buy it....from the US would preferable....thx
 

AKNate

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Look up the Social Medwork - they're in the Netherlands & seem legit. They sell a lot of drugs. I know that it's sold in india too... I'm sure there a lots of website you could purchase it from. It's an IV Drip though, how would you administer it? This is my biggest problem now.
 

lgelb

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I just want to note without relitigating all the data, that we don't have good data either that riluzole slows progression by 10%, nor that edaravone does so by 25%. Neither works equally well for all, starting early seems necessary for max benefit, and the "10% off what number" is a moving target, since quality of care aside from any drugs matters more than the drugs from what we are sure of as yet.

So anyone not taking the former or not considering the latter (esp. given the expense/logistics of an infused drug only approved in Japan), don't feel like you're not doing enough. There's plenty left to do, and you're probably doing it.

Best,
Laurie
 

Steven A Williams

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Hi All,
I have been taking Edaravone/Radicut for the past 4 days in Swiss Medica in Moscow. They are giving me two infusions a day each an hour long with 30mg Edaravone/Radicut in each. I read in the Mitsubishi Tanabe Pharma documentation that it should be 1 infusion per day of 60mg Edaravone/Radicut.
Has anyone else taken Edaravone/Radicut and what was your dosage regime?
Thanks,
Steve
 

AKNate

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My husband takes 60mg once a day & it takes him 45mins for the infusion. He does this Mon - Saturday with 1 day rest.

He mentioned today he has noticed twitching back in his calves - which as atrophied. Not sure if this is a good or bad thing, but he thinks it's good as it shows he still has muscle there.
 

Steven A Williams

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Thanks AKNate,
1 session a day would be so much easier mentally and on my arms. Not sure about how doubling Edaravone single intake will fair, but the literature recommends it, so it must be okay.
Anyone else taking Edaravone that can share their administration regime?
Steve
 

Firefly

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Or
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Hi everyone,

I had my 3 month clinic visit today. I asked my neurologist what he felt the chances of Edaravone being approved this June were. He stated it has been approved and he had already contacted our pharmacy to start the process of getting it on our formulary.

I questioned him on this. (I have bulbar so my way of communicating with him was via my model talker; I don't believe anything was lost in translation :confused:). I said I thought June 16th 2017 was when it would be reviewed by the FDA. He then said "well that was his understanding", that it had been approved.

I would rather my Neurologist be correct but have not read anywhere that it has been approved in the united states.

Can anyone help me clear this up?

Thanks so much
 

lgelb

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The FDA's decision is still expected in June. But payors know when those dates are, and make advance plans relative to formulary inclusion when they see the need or demand such as what this drug, if approved, will have.
 
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