Clinigen, Mitsubishi Tanabe Announce Early Access Program in Europe for ALS Therapy Radicava

Clinigen, Mitsubishi Tanabe Announce Early Access Program in Europe for ALS Therapy Radicava

Clinigen Group recently partnered with Mitsubishi Tanabe Pharma Corporation to launch an early access program in Europe for Radicava (edaravone), an intravenous treatment for amyotrophic lateral sclerosis (ALS).

The therapy is not yet approved in Europe, but the early access program will help make it available to patients who may benefit from it before its commercial launch.

“We are pleased to once again be working with MTPC to help eligible patients in Europe gain access to this important medicine,” John Lagus, head of managed access at Clinigen, said in a press release. “As the trusted global leader in access to unlicensed medicines, this partnership aligns with our mission of getting the right medicines to the right patient at the right time.”

Edaravone is already approved as an ALS treatment in Japan, South Korea, and the United States, where it is marketed by Mitsubishi Tanabe as Radicava.

In April 2018, Health Canada accepted Mitsubishi Tanabe’s new drug submission for edaravone, granting it priority review in the process.

Edaravone is a free radical scavenger, meaning it helps to remove free radicals from the nervous system. Free radicals occur as a normal part of a cell’s energy production process and are typically removed by the body; however, if they are not removed quickly enough, they can cause oxidative stress, which is believed to be one of the causes of nerve cell death in ALS.

In clinical trials, edaravone has performed well. In a Phase 3 trial (NCT01492686) evaluating the effectiveness and safety of edaravone in ALS patients, those on the therapy experienced 33 percent less decline in their revised ALS functional rating scale (ALSFRS-R) scores than those in the placebo group, after six months of treatment.

These results were considered statistically significant and were later published in the journal The Lancet Neurology.

In May 2017, the infusion treatment became the first ALS therapy in 22 years to receive approval from the U.S. Food and Drug Administration.

Radicava was described as a “minor miracle” for some ALS patients by Stephen Byer, co-director of ALS Worldwide, in a 2017 interview with ALS News Today.

“We have found and continue to find great benefit in terms of slowing, stopping and, in some cases, even helping to mildly reverse some symptoms of the disease,” he said at the time.

4 comments

  1. Charlie says:

    As Radicava has been used for some years in the Far East for pALS I feel we should be seeing data from the user population as to efficacy and enhancement of longevity.
    For example:
    How long must a pALS continue to be infused with it?
    What are the longevity aspects of Radicava patients compared to non-users?
    What numerical data is emerging as to long-term efficacy eg more than three years?
    Data should really be starting to emerge now from users in the USA although we might expect better and broader numerical information over the forthcoming two years and onward.

    Phrases like ‘…a minor miracle for some patients..’are unhelpful and veering toward obfuscation.

    Why is this ‘miracle’ not effective for all pALS using it? We know that some pALS would not have had access to it because it was proven ineffective for those who have had symptoms for over 15 months since onset. Are some pALS who were receiving it not responding?

    This whole situation raises more questions than answers, and now it appears that pALS in Europe will be invoiced/milked the equivalent of $140,000 per year of treatment.

    Just how good is Radicava ? (Answers not currently required from the sales-team or from professional ‘cheerer-uppers,’ thank you.)

    • Henry says:

      been under treatment since january(just completed the fifth period). My condition is stable. I had my first symptoms in january 2015, and have been taking riluzole and masitinib since march 2017. My condition was pretty bad by then, already confined in wheelchair and lost my speech. However, my breathing is still at an acceptable level and doesn’t require any help. This has not changed at all in the last 15 months. Whether this is due to effectiveness of one or the other medication remains to be seen as Im doing many other treatments which have never been discussed Here.

  2. Karl Wigler says:

    You printed (above) the following……..
    “Stephen Byer, co-director of ALS Worldwide, in a 2017 interview with ALS News Today”
    “We have found and continue to find great benefit in terms of slowing, stopping and, in some cases, even helping to mildly reverse some symptoms of the disease,” he said at the time.”
    These people are a scam…………
    ALS Worldwide provides counterfeit ALS drugs sourced from India. That “non-profit” provided Mr. Byer $1.2 million salary last accounts filed. See rch4.com/molecule

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