Edaravone APPROVED in US!!!

[Nikki J]

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm557102.htm

Great news! Not a cure or a miracle but very welcome!

 

[Nikki J]

More info
The ALS Association

 

[AKNate]

YAY!!!! And faster than what was hoped!!!

 

[Jrzygrl]

We were just talking with our ALS Clinic director about this at our visit today. She said she had heard maybe June for approval. Came home and an hour later, saw the ALS Association announcement! Happy day!

 

[Jocalyn8]

Great news, However, it won't be available until perhaps August. Does anyone know if we can fly to japan and pick it up and have it administered here?

 

[Jocalyn8]

AKNate,

How is your family member doing with the treatment in Japan? I believe they have been there a few months.
Thanks, Jocalyn

 

[AKNate]

Hey Jocalyn,

I'm with my husband now in Japan doing the last month of the treatment then bringing the medicine back home with us - i'm hoping this approval paves the way for us to get it administered easily when we get back, it has been a battle to try get any doctors to help so far.

He is going well, i wrote more about it in this post: https://www.alsforums.com/forum/als-drug-trials/37730-edaravone-4.html He is slow progressing so it's hard to tell. I thought his twitching was getting less however i think it's just up and down, his bicep today was twitching a lot and his right hand last night too. I'm worried it is progressing to his hands. But he did mention he was feeling weakness before he left on this trip... maybe the affects of the medicine will stabilize everything for now. His grip and pinch tests though are getting stronger every week for the past month, but his pointer fingers are weak to resistance (again, this was starting before the meds).

 

[AKNate]

Just found this on another forum too, looks like its 33% slow down rate instead of the 25% i initially thought: https://www.mt-pharma-america.com/wp-content/uploads/2017/05/Radicava-Product-Fact-Sheet_FINAL.pdf

 

[Vincent]

ALS Canada is already working to have this available in Canada. Not a cure, but praise God, a step in the right direction.
Vincent

 

[bkite]

Does anyone know, if Medicare or any other insurance, will pay the $146,000 per year for this drug that is given by IV administration?

 

[Nikki J]

How the insurance will play out is yet to be seen. Did you notice the company has set up a program to help work through insurance? You are supposed to call when you get a prescription. They said they would provide help through the process, and assistance with copays under some circumstances.

I do expect insurance companies to resist. It is a lot of money but some other diseases are very expensive - MS, HIV, cancer

 

[Kristina1]

So it won't be offered in a clinical trial-- it is already set to be offered just with a prescription?

 

[GregK]

So it won't be offered in a clinical trial-- it is already set to be offered just with a prescription?

Yep. follow the links provided above for more info. Expect to see it available this August.

 

[bigmark1954]

This will prolly be prohibitive for us non veterans......I seriously doubt private insurance would cover this.

Glass half empty........

 

[frankb]

Thanks, Nikki, for giving us a heads-up on this development. The als association article is really great info.