Edaravone (Radicava) approved to treat MND in USA – what does this mean for people with MND in the UK

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On Friday 5 May in America, the FDA, the organisation that approves drugs, announced that they’d granted a licence for the drug known as a Edaravone (to be marketed as Radicava ) for the treatment of MND. It’s unexpected news and we’re currently working out what this means for people with MND in the UK. Below is more information on what we know so far:

What is this drug and what does it do?
In clinical trials, Edaravone has been shown to slow the progression of MND potentially helping people preserve function longer. Some of the clinical trial results have shown that Edaravone only works on a subset of people at the early stages of the disease – we are seeking to confirm this.

Edaravone is an antioxidant drug that works by mopping up ‘free radicals’ in the body. Our cells have quite effective ways of dealing with free radicals, but these ‘cellular defences’ become less and less efficient with age.

As we age, our energy production processes lose efficiency, causing a ‘double-whammy’ of not only more free radicals being produced, but also less effective ways of dealing with them. When neurones are damaged, as happens with neurodegenerative diseases, then everything gets exacerbated even further, leading to a vicious cycle of events.

It’s a bit like sparks escaping from a campfire – if there are too many sparks and you don’t keep an eye on things, you could end up with the forest ablaze. There’s more information on earlier post on our research blog.

How would people take Edaravone?
Edaravone is administered intra-venously (IV). People with MND would receive the drug every day for two weeks, then take a break for two weeks. A company called Treeway are currently developing an oral preparation of the drug.

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.

Where can I find out more?
More information on Edaravone is available on the ALS Association website. More information on clinical trials in general is available on our website our website and in our research information sheet. As we learn more about the developments of the drug we will keep everyone updated.

13 thoughts on “Edaravone (Radicava) approved to treat MND in USA – what does this mean for people with MND in the UK

  1. My uncle is suffering from MND in India. This news brings a ray of hope to us. Can you please guide me further with regard to whom to contact to get more details.

    1. Dear Nirav,

      Thank you for your comment.
      We will be posting another blog article on edaravone in the near future so make sure to watch this space.
      If you have any specific questions, please email us at



  2. Is it possible to bring Edaravone into the UK as an individual for personal use?

    1. Dear Ann,

      We are aware that ALS Worldwide are helping some people with ALS in Europe to obtain edaravone based on their doctors’ referral.

      Best Wishes,


    1. Dear Anonymous,

      Please email us at so that we have your contact details.

      Best Wishes,


    1. Dear Malathi,

      Please contact the MND/ALS Association in India, who should be able to help you finding relevant resources:
      Alternatively, you can email us, the UK MND Association at

      Best Wishes,

      Research Development team
      MND Association

    1. Dear Laurel,

      The effects of edaravone on Progressive Bulbar Palsy are currently unclear.
      However, another drug called Nuedexta, which has already been licensed for pseudobulbar affect is due to start recruiting participants for a US clinical trial to explore its effects on bulbar function. You can find out more about the trial here. You can also find out more about Nuedexta at the ALS Association blog.

      Best Wishes,

      Research Development Team

  3. One of my friends suffering MND/ALS. He leaves I Romania and the doctors said that is no chance for him to find this medicine.
    Please let me know how can I help him!I leave in UK.

    1. Hi Ionut

      Thank you for your comment, my sincere apologies for the delay in replying. Unfortunately, edaravone is not licensed to treat MND in Romania. It may be possible to export it from a country in which it is licensed but your friend would need a prescription issued in Romania. He would also need to find a clinician willing to administer the drug. He would have to meet all the costs himself. I’m sorry that I can’t give you a more positive answer.

      Kind regards

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