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Thread: UK Approval for Edaravone

  1. #1
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    UK Approval for Edaravone

    Hi all,
    Since the FDA in the USA have approved edaravone for use in their country last week, the UK should try its damnest to do the same, asap so as to extend as many lives as possible. I have written to my MP, below, and have so far had no response.

    Can all forum members to do the same?

    Thanks, Steve

    To Stephen Hammond

    Dear Stephen,
    Hope you are well. Wondering if you could help me and save a few thousand people from early death.

    I have motor neurone disease, a terminal illness, which several thousand people in the UK have at any one time. A portion of these thousands die early and are replaced by new sufferers. There is a drug called edaravone, also called radicut and in the USA radicava that slows progression of the disease by 33% in patients in the early stages of the disease. Less effective in later stages, but it nonetheless still slows progression.

    It has been licensed in Japan, where it is made, for several years, and last week the FDA in the USA have approved it for marketing there. This FDA approval means that it is licensed in the USA, and patients will be able to receive its benefits soon.

    I have been to Moscow to have this treatment, and I must say that it definitely works. My progression has slowed down, probably more than the modest 33% they claim.

    Financially, it is not viable to take the medicine in Moscow at £5000 a session of two weeks, nor is it viable to take it in the UK as the drug costs £2200 for a month’s worth, and as it is administered over IV, the costs for a nurse to administer are £200 a day.

    So I was wondering if there was anything you could do to help it gain approval, to get it licensed in this country, as soon as it can be. This drug will save thousand and thousands of lives over the years, slowing the progression of the disease, enabling people to live longer and more healthy lives with symptoms reduced.

    Would you be able to help push the authorities to get this drug speedily approved?

    Really hope you can help.

    Thank you so much.

    All the best
    Steve

  2. #2
    Forum Member Alienista606's Avatar
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    unfortunately Parliament are dissolved now
    Need waiting for new one
    Last edited by Alienista606; 27th June 2017 at 13:18.
    Max

    @@@@@@@@@

    MND is stowaway on My life journey.
    Take free ride but I'M DRIVER HERE!!!!

    @@@@@@@@@

  3. #3
    Forum Member Ellie's Avatar
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    Steven,

    If a Pharma company hasn’t applied to the MHRA for a Marketing Authorisation, there’s not much an MP can do.

    In the case of Edaravone, the UK cannot grant it a Marketing Authorisation on 2 fronts: 1. It’s for a neurodegenerative illness and 2. It has Orphan status, i.e. a non-commercially viable drug, due to a relatively small potential patient cohort. Such MAs are granted by the EMA on a pan-EU/EEA basis.

    To this end, Mitsubishi Tanabe were granted Orphan status for Edaravone in 2015. This is not an MA, but means if an application is made, it should be expedited.
    Of course, this will all change for the UK when it leaves the EU.

    Ellie.
    ​Diagnosed 03/2007. Limb onset (arm) sporadic ALS/MND.

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  5. #5
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    Hi everyone
    Please can everyone sign this petition! It's in Dutch but it's to the European Medicnes Agency calling for the ALS drug Edaravone (which has been approved by th FDA) to be available to people with ALS in Europe. This drug can stop progression.
    Just fill in the bottom half of the form. Try and get as many people as possible to sign.


    https://secure.avaaz.org/nl/petition...rm=iwyDhb%2Bnl

  6. #6
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    Hi Jenny,
    I would sign but it is in Ditch, so I have no idea what I am signing. An english version would mean it would be accessible to many more people.
    Steve

  7. #7
    Forum Member Ellie's Avatar
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    The EMA is powerless to 'approve' a drug for which no application has been received. You are better off putting pressure on Mitsubishi Tanabe Pharma Europe, creator of Edaravone, to pursue an application for marketing Edaravone in the EU, which must be done through the EMA.

    To date, MT Pharma has not lodged an application with the EMA.

    I received this from Mitsubishi Tanabe Pharma today:

    "Thank you for your enquiry to Mitsubishi Tanabe Pharma concerning edaravone.

    Currently edaravone has only been approved and marketed for sale in Japan and South Korea. Radicava®(US brand edaravone) has now been approved in the USA by the FDA for use in the ALS indication. However it is envisaged that it will be about one to two months before everything is in place to market the product in the USA. Unfortunately 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. There are no immediate plans for submission for a licence to the European Medicines Agency (EMA) as they require different data to their counterparts in the USA and Japan to support a licence application.

    Mitsubishi Tanabe Pharma, took the decision to pursue an Orphan Drug Designation with the EMA in the hope of being able to expedite the availability of edaravone to the whole of the EU ALS population through the centralised regulatory procedure (i.e. applying for one licence for the whole of Europe rather than having to seek an individual licence through each member state). Discussions with the Agency are ongoing and at this stage it is not possible for us to determine when a licence submission can be submitted

    Please be assured that Mitsubishi Tanabe Pharma are doing all that they can to make edaravone available to ALS patients throughout Europe.

    Kind regards
    Mitsubishi Tanabe Pharma Europe Ltd"


    Ellie.
    ​Diagnosed 03/2007. Limb onset (arm) sporadic ALS/MND.

  8. #8
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    Thanks Ellie

    In that case lets all contact the EMA and ask them when Radicava will be available in Europe, we need to let them know people need this asap.
    http://www.ema.europa.eu/ema/index.j...01ac05806499f0

  9. #9
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    Ellie:
    Thanks again for an informative and realistic response. We are all impatient to get access but your sobering mail brings us back to earth. It will be a long time before it is accessible in he UK. Sad but true.

    Charles

  10. #10
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    I hate to say it but every neurologist I have spoken to over the past few months who specialise in MND don't think very highly of this new drug based on the results of the research that has been conducted...they were very surprised that it got approval in the US.

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