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Thread: Radicava (edaravone) approved by the FDA in the US

  1. #11
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    A big YAY Barry!

    I know they will also communicate via email, and if need be will send someone to your home.

    The more I read deeper into this organization the more aware I became of how they can cross boundaries to help those around the globe effected by MND/ALS

    The bottom line is they are another resource to tap into if need be, and may be able to provide additional support in areas that your NHS might not be able to cover.

    Nothing to lose, and much to gain in my opinion.

    Good luck Barry, keep me posted

    xox
    .

  2. #12
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    CC:
    Your interest and work is much appreciated this side of the pond. Thank You.

    Barry: good on you.
    I would not worry too much about being understood. Those Americans would struggle to understand your accent at the best of times.
    Charles

  3. #13
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    My pleasure Charles even if it’s in the smallest of ways.

    Have to say we Americans absolutely adore your accents !

    For some bizarre reason my daughter attempts to speak in it often. She says ‘Ello Mummy’ to me all the time, and when we go out to restaurants to eat she orders her food to the waiter in a British accent and she is very serious about it too. When I ask her after the waiter leaves ‘Why are you talking like that??’ she will say in a British accent to me ‘Talking like what Mummy??’ She cracks me up LOL

    I recently watched this movie in set in your country called ‘Love Actually’ with Hugh Grant and lots of other famous British folk, it was about all different kinds of love relationships. This one character a young guy couldn’t get ‘shagged’ (as you British say) so he figured he would come to America because American girls LOVE your accents (he is so right!). So he buys a ticket to Wisconsin! LOL gets off the plane as tells the cab driver to take him to any bar, just any bar in Wisconsin. He orders a drink, and this pretty girl at the bar hears his accent, and next thing you know he is sitting at a table with her and some of her friends, and they are asking him to say random words just so they can hear his accent. It’s hilarious!! He did get shagged with the girl and all her friends! LOL This movie had a great soundtrack too loved the music in it

    xox
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  4. #14
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    May 06, 2017
    FDA Approval of Edaravone
    By: ALS Worldwide

    A CAUSE FOR CELEBRATION

    The anticipated FDA approval for Edaravone, also known as Radicava, has arrived a full month earlier than expected. On Friday afternoon, May 5, 2017, FDA authorization was granted to Mitsubishi Tanabe Pharma America, Inc. to manufacture and distribute this important medication that has already provided systemic benefit to many with ALS in Japan, India and to smaller patient groups, in at least 16 other countries, including the US.

    At ALS Worldwide, we have had first hand experience providing compassionate use of Edaravone to a group of ALS patients since September 2016. Because of the positive trial results shared by Mitsubishi Tanabe at that time, we felt it important to enable this medication, on a compassionate use basis, to those who sought Edaravone and were able to manage the challenges Edaravone encompasses. Some US and EU patients traveled individually to Japan to bring back a several month supply for themselves. For others, we traveled abroad to import this medication for its compassionate use trial, and benefits, in the US and other countries.

    We learned that the majority of those who began its use, now for as long as 12 months, have achieved benefits that outweigh some of the challenges involved in its administration. Edaravone, or Radicava, requires a PICC line or Port-A-Cath for daily intravenous (IV) injection and can take up to an hour for the daily infusion to be completed. For most, this was achieved in-home and soon became an acceptable part of their daily routine.

    After 22 years since the introduction of Rilutek (generic name riluzole), we appear to have a new systemic treatment that offers important benefits to the ALS patient community. Radicava, as it is now named in the United States, is expected to be available to patients and their doctors as early as August 2017 but may be up to three months later.

    In months past, ALS Worldwide has responded only to specific patient inquiries for individual compassionate usage of Edaravone, funded in whole or in part by patients and families themselves. Our role included sourcing and importing the medication, confirming its authenticity and safety, continuous monitoring of usage and helping develop local medical oversight, administration of Edaravone, and correlation of patient usage and results. ALS Worldwide has provided like services for other trial medications under the supervision of our medical and scientific advisors, to whom we are deeply indebted. This effort is part of our ongoing effort to support the ALS patient community as we have done since 2002.

    What can you do now that Edaravone has been approved?

    1. In order to make an informed decision about the usage of Radicava, learn what is involved in procuring a PICC line or Port-A-Cath by reviewing this document: Stanford Hospital Patient Information
    2. Notify your local pharmacy that you wish to be informed as soon as Radicava becomes available
    3. Contact your insurance company concerning their coverage for Radicava
    4. Discuss the installation of the PICC line or Port-A-Cath with your local physician

    FDA News Release
    Mitsubishi Tanabe Pharma Corp news release of estimated infusion cost.

    ALS Worldwide began informally in 2002 when our son Ben Byer was first diagnosed with sporadic ALS. Our efforts for Ben and eventually thousands of other patients, now in more than 125 countries around the world, has continued as a not for profit organization since 2008.
    Today, we strive to help people with ALS live better and longer lives by providing compassionate care and counseling, assistance in managing ALS Symptoms, greater access to beneficial medications, information about medical devices and communication systems, caregiver support, and guidance on healthcare topics and resources.

    You can learn more about ALS Worldwide through the following venue:
    https://www.facebook.com/ALSWorldwide/
    .

  5. #15
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    Hi - I'm coming up to 3 years since this disease started. This drug slows the progress down for an estimated 6 months. At which stage do you say that I don't want it to slow down? I want a cure rather than something to slow it down. I cannot get excited about this news.

  6. #16
    Forum Member Ellie's Avatar
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    In the absence of a cure, I reckon people would be extremely happy to slow down their progression, especially as Edaravone worked best in the newly diagnosed (according to the trial data)

    We'll see when it's available in the U.S. this autumn.
    ​Diagnosed 03/2007. Sporadic Definite ALS/MND Limb Onset.
    Eye gaze user - No working limbs - No speech - Feeding tube - Overnight NIV.

  7. #17
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    Thank you for your enquiry to Mitsubishi Tanabe Pharma Europe concerning Radicava(r) (edaravone).

    As you state Radicava(r) has now as of Friday been approved in the USA by the FDA for use in the ALS indication. However it is envisaged that it will be about three months before everything is in place to market the product in the USA. Currently edaravone has only been approved and marketed for sale in Japan and South Korea. The Mitsubishi Tanabe product is not current available in any other countries and there is no named patient supply/patient support program for edaravone nor any active clinical studies in ALS patients. Mitsubishi Tanabe Pharma is currently not able to supply the product anywhere outside Japan and South Korea and then only through the organised healthcare distribution network.

    Mitsubishi Tanabe Pharma is try to make this drug available in other regions. However at the moment, no decisions have been made.

    I am sorry not to be able to provide you with additional information at present, but thank you again for your enquiry.

    Kind regards

    Mitsubishi Tanabe Pharma Europe

  8. #18
    Forum Member Barry52's Avatar
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    Thanks for posting this Steve. Not an unexpected reply but at least you have cleared it up for others.

    Barry
    Iím going to do this even if it kills me!

  9. #19
    Quote Originally Posted by Redders239 View Post
    Hi - I'm coming up to 3 years since this disease started. This drug slows the progress down for an estimated 6 months. At which stage do you say that I don't want it to slow down? I want a cure rather than something to slow it down. I cannot get excited about this news.
    I agree. Actually the trial showed a reduction in decline from (on average) 7.5 alsfrs points to 5.01 points over the 6 months of the trial. Everyone declined by 5.01 points, which as we all know is significant disability. It does not relate or map to 6 month delay. It cannot be extrapolated.

    Now with the highly subjective nature of some alsfrs points, this as you say is really not that exciting.

    Also it does appear to be in first year or months from diagnosis (although I haven't seen the detail here). Now not wishing to be more difficult, but we all know that the wide variation in this disease, especially in Year 1 or 2 when our bodies can actually adapt better than imagined and dare I suggest that our alsfrs scores can go up and down?

    But the press/awareness that we can get will be great.
    Last edited by Onein300; 9th May 2017 at 14:02.

  10. #20
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    True not the cure, but still a reason to be positive because its something that worked and shows some progress is being made, and where this worked something even better can and will come as scientists, and researchers are encouraged to push harder. Who knows maybe when more people have access to it there will be more positive reports about the effects of it ...

    Even small step forward is better then no step forward, even though its not enough for so many that need much more, and need it now.

    xox
    Last edited by ccinjersey; 9th May 2017 at 17:10.
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