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

  1. #1
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    Radicava (edaravone) approved by the FDA in the US

    http://www.alsa.org/news/media/press...ug-050417.html

    But will it get approval in the U.K.?

  2. #2

    Approval process - MNDA please comment

    Quote Originally Posted by GemmaPob View Post
    http://www.alsa.org/news/media/press...ug-050417.html

    But will it get approval in the U.K.?
    This is the most significant news for over 20 years.

    Forum monitors can you please bring to attention of appropriate Mnda management (they are almost certainly aware)

    We need a formal review/plan of action etc.

    One more step!

    Onein400

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    Massive news.

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    Forum Member pete's Avatar
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    Quote Originally Posted by steve001 View Post
    Massive news.
    It may well be but at $146 k a year for six months extension ?? Is it a NHS option ?
    All I need is a miracle

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  6. #6
    Quote Originally Posted by steve001 View Post
    It's good news, but there has to be a solid calm approach to it.

    It's needs to be a pill really, for a small effect drug. The focus should be on developing that pill.

    But it's great news for awareness month which is just coming in June!

    One small step,

  7. #7
    Forum Member Barry52's Avatar
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    Hi all,

    Great news indeed and now the MNDA needs to focus on how to campaign for approval in the UK. I suspect the EU will have it's own agenda on approval and whilst we are still in the "club" we don't want to start the process alone in 2 years. I and no doubt others will be raising this next month at the AGM meeting in East Midlands.

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

  8. #8
    Forum Member Ellie's Avatar
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    https://mndresearch.wordpress.com/2017/05/06/edaravone-radicava-approved-to-treat-mnd-in-usa-what-does-this-mean-for-people-with-mnd-in-the-uk
    /


    The pertinent bit being:

    What is the process for licencing this in Europe?
    We are in contact with Mitsibushi-Tanabe in the USA and have asked them to connect us with their European office in order to understand their plans for licensing in Europe.

    The company will have to apply to the European Medicines Evaluation Agency. The drug has already been registered with EMEA as an orphan disease candidate, which means that any licensing application will be fast-tracked. EMEA approval, however, does not ensure UK approval and the drug would need to be approved by the Medicines and Healthcare Regulatory Agency. New medicines are usually also reviewed by the National Institute for health and Care Excellence, which makes recommendations on the cost-effectiveness to the NHS. There is a process for joint MHRA-NICE review which the company will doubtless pursue.
    The licencing process does take time, so the company could also apply through the Government’s Early Access to Medicines scheme, which aims to make a drug available where marketing authorisation is not yet approved and there is a clear unmet medical need.
    Last edited by Ellie; 6th May 2017 at 12:24.
    ​Diagnosed 03/2007. Sporadic Definite ALS/MND Limb Onset.
    Eye gaze user - No working limbs - No speech - Feeding tube - Overnight NIV.

  9. #9
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    Just a suggestion, all those living with this illness might want to consider also registering in ALS Worldwide. The reason being there is a woman in Cambridge, England that is getting Nuedexta the medication available here in US for emotional liability that is not available in the UK, but this Cambridge woman is getting it shipped to her with the help of ALS Worldwide.

    If Edaravone becomes available in the US, but with greater difficulty in the UK it may be possible that ALS Worldwide could help each individual that wants to try it obtain it.

    This organization too have been monitoring the progress of Edaravone and did a write up about on their site.

    xox
    .

  10. #10
    Forum Member Barry52's Avatar
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    Hi CC,

    Thanks to your pm I registered with ALS worldwide and got a same day reply. They want me to arrange a webcam discussion of 30 minutes duration. That will fun for someone who can barely make their family understand them.

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

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