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Thread: UK Approval for Edaravone

  1. #11
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    Riluzole is worse

  2. #12
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    From the EMA

    Thank you for your query of 7 July 2017 regarding the medicine edaravone which has recently been authorised in the USA under the trade name Radicava.
    The European Medicines Agency (EMA) fully understands the need for new treatment for patients with amyotrophic lateral sclerosis.
    In order for EMA to be able to evaluate a medicine for the purpose of placing it on the market, we need to receive an application from the pharmaceutical company who has developed the medicine. Unfortunately, EMA has to date not received an application for a marketing authorisation for edaravone.
    However, we already looked at this medicine in 2015 and 2016 and designated it as an ‘orphan medicine’. In fact an orphan designation was granted by the European Commission to 2 companies (Treeway B.V. and Mitsubishi Tanabe Pharma Europe Ltd.) developing edaravone for the treatment of ALS. If a medicine is designated as an orphan in the EU, the company developing this medicine has access to several incentives which foster and speed up the development of such medicine. The granting of orphan designation does not mean that a medicine is authorised for use. The medicine will still need to be evaluated by EMA if and when either company decides to submit an application for marketing authorisation. The standard evaluation time is about one year for a marketing authorisation application.
    For further information about these orphan designations, please visit the following web pages:
    http://www.ema.europa.eu/ema/index.j...01ac058001d12b
    http://www.ema.europa.eu/ema/index.j...01ac058001d12b
    EMA publishes a list of all medicines that are under evaluation. Should a marketing authorisation application for edaravone be submitted to EMA, it will be included in the list which is published at the following link:
    http://www.ema.europa.eu/ema/index.j...01ac05805083eb
    Please note that for patients, who have a disease with no satisfactory authorised therapies or who cannot enter a clinical trial, it may be possible to receive medicines that are not currently authorised through so-called compassionate use programmes.
    Compassionate use programmes are regulated by national legislation and the way they work may vary from country to country. (more information on what a compassionate use programme is can be found on the following link:
    http://www.ema.europa.eu/ema/index.j...01ac058007e691).
    You may wish to contact a patient organisation, such as Eurordis (http://www.eurordis.org/), or indeed the companies may be able to assist you with information about compassionate use programmes and their future marketing plans.
    We hope you find this information helpful. We would be grateful if you could take part in a short survey on our service, which you can access through the following link:
    https://ec.europa.eu/eusurvey/runner/AskEMA
    Kind regards,

    Inga Abed

  3. #13
    Forum Member ccinjersey's Avatar
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    A recent article on ALS Worldwide

    xox

    *****

    ALS Worldwide
    July 10, 2017

    You can be hopeful with ALS. Here’s why!

    While tremendous work remains to be done to address the unmet medical needs of the estimated half a million ALS patients worldwide, there is more hope for the future than ever before.

    Just now, the new drug Radicava (generic name edaravone) has been FDA approved and many in the ALS community have been using edaravone through ALS Worldwide or will begin to use it through their insurance-covered program now being established by MT Pharma US. Edaravone has dramatically furthered the now 22-year old riluzole treatment and several other new compounds are taking shape.

    Symptom management has improved significantly. The pursuit of personalized treatment through a quality multidisciplinary clinic, maintaining muscle mass through exercise, focusing on optimal nutrition, and developing a positive attitude can help patients live longer and enjoy more productive lives.

    Never before have we seen such a high level of activity and enthusiasm among ALS researchers. Each day brings new reasons to be encouraged that scientific breakthroughs are within reach, and we will not quit until ALS is a controllable disease or syndrome. Until then, we’re on a mission to spread hope and share this simple message: Each of us has what it takes to be part of the solution and galvanize progress toward a cure.
    Love feels no burden, thinks nothing of trouble, attempts what is above its strength, pleads no excuse of impossibility; for it thinks all things lawful for itself, and all things possible.

  4. #14
    Forum Member ccinjersey's Avatar
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    July 10, 2017

    More results are in! Edavone shown to provide greater benefits to ALS patients after one year

    By: ALS Worldwide

    "Data from the open-label extension trial of Edaravone (Radicava) in patients with ALS demonstrated the drug continued to provide benefits after 48 weeks of treatment. These findings were presented by researchers from MT Pharma America, the company which manufactures Edaravone, at the May 18-20 European Network for the Cure of ALS (ENCALS) Annual Meeting.

    'The 12-month data presented at ENCALS suggest early intervention with Radicava may lead to a meaningful clinical benefit when promptly initiated in people with ALS, as opposed to being delayed by six months,' Dr. Jean Hubble, vice-president for medical affairs at MT Pharma America, said in a press release.

    The trial extension compared patients who had taken Radicava for 48 weeks to those treated with placebo for six months in the original Phase 3 trial, before switching to Radicava for another 24 weeks in the open-label study. Measurements of the ALS Functional Rating Scale-Revised (ALSFRS-R) showed that those who received Radicava for the full 48 weeks had significantly less physical decline and an about 58 percent lower relative risk of death or certain disease progression events."

    Read the full article entitled Radicava Upholds Benefits

    ALS Worldwide is in agreement with MT Pharma's findings, based upon observations and results from our edaravone compassionate usage with patients over the past year. Our supervision of these trials suggests the benefits of edaravone occur, to a somewhat but still very meaningful level, in patients of greater than one year duration of disease WHEN BEGINNING the protocol. Further, patient benefit continues AFTER a one-year period of using Edaravone. Results showed the positive impact of the drug to be greater after one year of use as opposed to near the beginning of the trial. The drug appears beneficial for an indefinite period of time.

    FDA approved Edaravone for ALS on May 7. To learn more about the FDA approval, please visit: Edavavone

    We will continue to monitor and report all updates on Edaravone and its use for ALS patients, and we hope the results continue to show great promise and hope for all in the ALS community.
    Love feels no burden, thinks nothing of trouble, attempts what is above its strength, pleads no excuse of impossibility; for it thinks all things lawful for itself, and all things possible.

  5. #15
    Forum Member Onein400's Avatar
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    Quote Originally Posted by steve001 View Post
    Riluzole is worse
    Untrue!!

    Riluzole was PROVEN in 3 separate18 month studies with over 1800 patients. Also riluzole studies measured a precise point, i.e. Time to trach or death rather than a highly variable reduction in decline in alsfrs ratings.

    The general consensus in Europe, and it is fact, that a further trial is needed before there any chance of approval in Europe. MT haven't even applied. Treeway are going to embark on an oral form trial, but that appears a while off.

    But the statement that riluzole is worse is incorrect. It is still the best treatment if you have no adverse reactions.
    Last edited by Onein400; 29th August 2017 at 10:24.

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