9 Things to Know About the New ALS Drug Radicava

May is ALS Awareness Month, so it is timely that on May 5, the FDA approved the first new treatment in 22 years for amyotrophic lateral sclerosis (ALS). The drug, Radicava (edaravone) has been found to slow down the decline of physical ability in ALS patients by a third. Find out more about the FDA approval of Radicava here. 

MORE: May is ALS Awareness Month.

Here are some important things to know about Radicava:

  • The drug underwent a phase 3 clinical trial in Japan and South Korea where 137 ALS patients were given either Radicava or a placebo. The group given Radicava experienced a 33 percent reduction in the decline of their physical abilities compared to the placebo group.
  • Radicava works by reducing the oxidative stress in the body. People with ALS have high levels of oxidative stress.
  • Radicava is administered via intravenous infusions. Initially, patients have a daily infusion for two weeks and then have two weeks rest. After that, they need to have 10 consecutive daily infusions followed by two weeks rest.
  • Each infusion takes around an hour to complete.
  • The dosage of each infusion is 60mg.
  • The cost of each Radicava infusion is $1,000 and treatment costs $146,000 annually.
  • Radicava should be available to ALS patients in the U.S. by August.
  • The most common side effects associated with the drug are headaches, bruising and gait problems.
  • Radicava infusion contains sodium bisulfite which is known to cause both mild and severe allergic reactions in some people (particularly those with asthma).

MORE: Understanding the neurons behind ALS.

ALS News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or another qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website.

17 comments

  1. Allan Moore says:

    sure thing I cannot get out of a wheelchair without a lift, have no transportation wheelchair van, legs and most of my arm movement is gone,,,,have no way to raise 146,000 to try even if i had help a port would have to be put in,,,,, I still have speech, breath ok and can eat ok but how could anyone at 71 with medicare do this ?

  2. Nina says:

    Dear friends,
    This is not for ALS patients, this is for pharmaceutical companies and their owners’ pocket. They made this drug for themselves to do bussiness and make money and not for people who suffer from ALS. The price is so high people can not reach this treatment, even if they pay 150.000$ annually they are not promised anything, even slowing down the process is under the question ,,yes or not”, or ,may’. Please, if there is any hope, do not make this hope non-available for us…..We know all these clinical trials need money to be performed, but ingredient of drug is not expensive itself and
    Make the drug cheaper…

    • Bernhard says:

      Ja, Nina, leider hast Du wohl recht. Ich habe ein gutes Einkommen. Aber die Kosten kann ich nicht aufbringen. Meine Krankenversicherung tritt hier nicht ein, da in Deutschland nicht zugelassen. Liebe Grüsse, Bernhard

  3. kj kerl says:

    It’s my understanding that each Radicava infusion costs equivalent of $100. in Japan. Why is it priced at $1,000/infusion here? Sounds like too much capitalism. Who has an extra $12k/month? Will I will need to pass on it and just die a year earlier? Maybe we PALS (Persons with ALS) should all move to Cuba? I understand Cubans have better medical care and a longer average lifespan than Americans also, with their poverty-stricken medical establishment and poor economy too! There are already huge medical migrations to India and other countries with saner public health systems (for example elective surgeries costing 10% of the US alternative). That’s an embarrassment to the American medical establishment (and maybe to US diets and lifestyles also?). I hear some progress is being made with more MD’s starting to be employed on (good) salaries, not by crazy piece-work compensation. And medical groups need to be incentivized to work on better out-comes, not by volume alone, with non-competitive hidden fee schedules. Nuff said. Klaus in Seattle.

    • Natalie Bernardo says:

      Its an FDA approved treatment, so no reason Medicare and insurance won’t pay. Also, ALS foundation is planning assistance. Check with your local agency.

  4. Jeannette Varela says:

    It is absurd and outrageous what our country, USA is doing with patients suffering ALS. $146,000.00 cost of medicine a year for a medication that it isn’t even proven to do much more than possibly slowing down the progression of the disease. My nephew, a 31 year old was diagnosed about a year ago with ALS, has a 2 year old baby, whom he wants to see grow up. How does he do this if he can’t afford the cost of the medication? I have been an active supporter of ALS Foundation ever since a friend of mine was diagnosed with this illness 20 years ago, she only lived 2 years after the doctor told her what she had. Unfortunately, there were no drugs to delay the inevitable outcome. Now, I am facing this problem again with a member of my family, where does one go for help? The cost of this medication should be absorbed by the Insurance companies or the government. I find this to be very frustrating!!

  5. Peter Byrne says:

    Charging $146,000 annually is a disgrace to the human race and no different to putting a gun to someones head and demanding a ransom. We cannot afford anything near that so we wont get the ‘possible’ 33% slowdown.
    Mitsubishi Pharma Tanabe do not need to charge this. In 2016 their revenue was 426 billion with net revenues 59 billion, they have 441 billion stored in cash and all those are forecasted to increase!! See here https://markets.ft.com/data/equities/tearsheet/financials?s=4508:TYO
    In terms of them justifying their costs lets not forget Edaravone (ingredient for Radicava) was first developed for stroke many years ago so one could argue a lot of research has already been paid for.
    I hope the Dutch Company Treeway get their FDA approval for a tablet version of Edaravone wipe these guys off the market, provided they have a reasonable price. Treeway are also researching for a solution to first stop and eventually cure, they were involved in the success against HIV.

  6. Mosca Grazia says:

    Does anybody know how to purchase this medicament in Japan? I’ m living in Italy and I really need to try this medicament…like anyone who is hoping to find a solution to this terrible desease.
    Thank you
    Grazia

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