9 Things to Know About the New ALS Drug Radicava

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: Four treatments that can improve life with ALS

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 60 mg.
  • 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: TV presenter talks about her father’s journey with motor neuron disease

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39 comments

  1. Barry Wilson says:

    The image associated with this post is misleading as it shows tablets when the drug is clearly applied intravenously.

        • Judy says:

          Not funny! If you had a family member or friend diagnosed with ALS you would realize that ALS is nothing to joke about.

        • Karen Holt says:

          Totally agree Judy, my husband of 26 years was diagnosed with ALS in Jan 2017. He is a military veteran,& was a praise and worship leader at our church, until the disease took away his hand functions and can no longer play guitar. This is a terrible disease that our family has to live every day. Really nothing to be sarcastic about. Jeff I would suggest you go to the http://www.als.org site and read about ALS. Maybe next time you will think and research before you type.

          • Doreen says:

            Karen I know what you ar going through my Dad was diagonsed at the age of 83 and is also a veteran and only has affectd his hand function also. I pray everyday for no family or indivdual to go through this. Prayers to all this is affecting.

          • Marleen Burgess says:

            I have MS. I take Protandim which decreases oxidative stress by 45% in 30 days. We all have oxidative stress. I have been taking this for 3 yrs. and can do anything I want to. It’s not meant to cure or diagnose but has helped a lot of people I know.

  2. T Reed says:

    I get that you are trying to be funny, but clearly you are not personally affected, nor do you love someone personally affected by this disease.

    • Bill says:

      I have ALS, and I though the 45 years, was Funny…. Lighten-up, Cheer up, as that goes a LONG..Long way in living longer, in my condition! And I SURE as Hell can’t afford to spend $146K on treatment…. LOL!!

      • JH says:

        We have patient assistance programs in place to help. Please don’t think that we can’t help because the cost of the drug itself.

        • Glen Hopkins colon says:

          I’m hoping that the new radicava will help slow down the disease long enough for them to find a cure I was diagnosed almost 3 years ago and will be in a wheelchair in the next few months

        • DMason says:

          JH, What kind of assistance programs do you have? My dad has ALS. He currently has no use of his extremities and he is on a vent… We are currently waiting on Medicare to approve this treatment for him.. PLEASE HELP….

          • J says:

            Trying contacting the ALS Association for assistance. You would need a lawyer & support group to fight for treatment. My friend has HMO and was denied. We participated in the ALS Walk and the support given by the association help him get the treatment started.

    • david cast says:

      All I can say to you about having ALS is that it really sucks and is very hard for that person and family… Imagine being told by your MD that you have a very ugly and aggressive disease that we know nothing about???
      Not so Funny at that point.

  3. Peter Davey says:

    I have suffered from this disease for over 11 years and I actually thought that comment WAS funny.
    Give the guy a break!
    Humour is a positive tonic which keeps me going .
    Positive attitude and having a laugh is everything good and helps overcome the looming dark clouds above.

  4. Carol says:

    I heard that mass general hospital has the drug but cannot administer until greedy infusion companies figure out price points. I thought this would be figured out by now. The hospital tells patients it’s there, but they can’t have it. How do these ceos sleep at night?? They raised it from 65,000 to 90,00 or something like that. It’s not right. It’s unethical and it makes me so mad, and sad.

    • Louis says:

      Now available in some parts of US and should be available everywhere by end of October. Searchlight offers a discount and your insurance should cover some cost and what about Medicare. It will be expensive and you have to be your own advocate. I find neurologist monitor progression and suggest exercising. Research is making strides,,,,,,,,,,,, for future victims

    • Lynda says:

      Its probably the drug that Israel has developed. They also did a study at Mass General with it. They were able to duplicate the same results that Israel had. Its suppose to be a pretty big improvement.

  5. Rania Rapti says:

    Hello everyone….does anyone know how this drug works?my father is struggling with the disease and we re trying to get the drug to greece….if anybody can help with any info please do….

  6. I have had ALS for 2 years. What bothers me is that the drug will only keep give you an extra 2 to 3 months for $ 150k
    Why can’t they find something that will slow down the process for years instead of months ?
    I am deteriorating fast

    61 yo Rehoboth DE

  7. Tracy Taylor says:

    My cousin is very missed he was diagnosed Aug2015 and passed 3 months later on Nov.4 2015,”a day a lot of us will never forget “ALS really takes a toll on a person and ther family ,FIND A CURE!!

  8. Al Arnal says:

    I was told by my doctor that I did not meet the requirements to receive Radicava, you have to be in the early stage of ALS. Pittsburgh Pa. 1 1/2 yrs with ALS

    • K. Kang says:

      The FDA approved Radicava for ALL ALS patients–not just early stage. My husband was diagnosed 4 years ago, is in a wheelchair with little use of arms, hands and legs, and has a forced vital capacity of less than 70%. Yet, he was approved by Medicare/SilverScript for Radicava. (By the way, if you have ALS, you can immediately qualify for disability and Medicare.) You can additionally apply for a grant from the Healthwell Foundation https://www.healthwellfoundation.org/patients/how-to-applyapply-online/ Even if you make 5x more than the federal poverty limit, you can be eligible for a grant to help pay for Radicava. Do look into it–we’ve heard that one woman who started taking it in Japan and now is getting infusions here states that her disease has not gotten worse since taking Radicava. She’s had ALS for 4.5 years and is wheelchair-bound.

  9. Mahesh K Patel says:

    My brother got diagnosed with Bulbar ALS in September 2017, however the insurance refuse to administer Redicava because he does not have the forced vital capacity (lung test) equal to or>80%. What a Joke! The insurance company wants the money but does not want to provide service. I have asked his doctor to appeal. Can anyone help!!

    • Friendly says:

      Masitinib was also on trial for approval, it has a different mechanism of action but the article I read seemed to have positive results even in late stages, and when I googled the the cost it is a lot cheaper. The journal article sites study doses at 3-4.5 mg a day and I saw a on online pharmaceutical company that does wholesales carrying it for 100mg/$150…….I pray for your brother’s healing, physical and spiritual strength .

  10. R.G. Straight, FNP says:

    I am a health care provider and find much difficulty in getting patient referred for the appropriate diagnosis, follow up and treatment. trying to get patient in to see Neuro and genetics in Denver – getting nowhere, very frustrating for patient and family as well as me. Patient is very worried and I fully understand the frustration – I would be angry if I were in the situation. I find many excuses as to why the referral information never gets to where it needs to be to get the patient fully evaluated. I would expect more support for patients and health care providers from the centers with the expertise (being too busy or high patient load does not cut it with me)!!!

  11. Richard Saliba says:

    Why would anyone to prolong this cruel disease for which there is no cure available or rumored. My mother and two close friends both died from ALS and I wouldn’t have wanted to watch them suffer one more day.
    If you have to catch it early to use Radicava there lies another problem, it is hard to diagnose quickly from what I have seen.

  12. Doreen says:

    Has anyone contacted your local senators in the help with this?
    My Dad who is 85 has decided not to receive it.
    You have a to be a adovocate for them if they are not to for them self. I understand what all of you are going through. As I am one of my Dads caregivers on a daily basis with this awful disease.

  13. Rosa says:

    My husband is a Vietnam Veteran who was diagnosed with ALS, 15 months ago. His is ALS with respiratory failure. I am him his caregiver and work full time. I understand trying to laugh where there is despair but this disease is horrible and cruel. It seems he has had it for 2 years prior. He was always so tired. He came back with asthma from Vietnam. He had open heart surgery about 22 months prior and was suppose to feel better. Cardiologist and Pulmonary played kick the can with him for a year stating it was not them, go back to the other. He was still tired, and informed his primary doctor who sent him to a neurologist. we were given the heartbreaking diagnosis.

    I understand trying to make light of the situation but as a caregiver, there is nothing humorous about ALS. My husband thanks me fir what I do for him. I tell him I don’t mind, as I do not believe I would do as good as he has. I asked him which was tougher – ALS or Vietnam. He said ALS. I felt sick yo my stomach. This man was never welcomed and mistreated when he came home. He survives a horrible war, to come home to ALS.

    I have been humbled. I hope to be more compassionate person.

  14. Doreen says:

    Rosa you are correct ALS is a horible disease and to see your love one suffer from this is awful. My Dad will be 86 at the end of the month and and he is losing all mobility in his arms. Breaks my heart to see him try to feed himself. Please know you are not alone. I will pray for you and your husband.

  15. ALS Helper says:

    The company that produces Radicava has a program called Searchlight that provides up to $20,000/year in assistance to each patient to help with their out of pocket costs. The company’s name is Mitsubishi Tanabe. There is a limited number of infusion pharmacies in each state that Mitsubishi Tanabe has offered this therapy to. Radicava was fast-tracked by the FDA to the U.S. based on positive study results in Japan and South Korea and was approved in August of 2017.

  16. Patty says:

    When in doubt, GOOGLE is your friend. I research health, diet and nutrition mostly as it relates to heart disease which can also be impacted by oxidative stress. I tried to choose an article that explained it in basic terms, but I recommend you all do your own research on oxidative stress. Foods and supplements can help with oxidative stress. Vitamin C is a powerful antioxidant! Not sure if it would be counter indicated with Radicava, but it is certainly worth looking into.

    https://www.wallerwellness.com/what-is-functional-medicine/understanding-oxidative-stress

  17. Friendly says:

    I agree. It’s important to optimize everything. Relieve spiritual stress, relieve physical stress (yoga, omega fatty acids, vitamin E) . Optimize muscle and nerve health with iron , vitamin D, mg ( topical mg oil/ lotion) calcium, b 12 , B.Vitamins, acupuncture, healthy lifestyle low carb/gluten lean protein , no smoking etc.

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