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Thread: UK Approval for Edaravone

  1. #11
    Forum Member
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    Jun 2016
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    22
    Riluzole is worse

  2. #12
    Forum Member
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    Jun 2016
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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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    Sep 2012
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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.
    May God grant you always.. a sunbeam to warm you, a moonbeam to charm you, a sheltering Angel so nothing can harm you, Laughter to cheer you, Faithful friends near you, and whenever you pray Heaven to hear you -

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