Radicava, First Approved Therapy for ALS Since 1995, Now Available for U.S. Patients

Radicava, First Approved Therapy for ALS Since 1995, Now Available for U.S. Patients

Radicava (edaravone), the first new medication for amyotrophic lateral sclerosis (ALS) in 22 years, is now available in the United States.

Approved May 5 by the U.S. Food and Drug Administration (FDA) for all U.S. adults diagnosed with ALS, Radicava has been shown to slow the loss of physical function in ALS patients by 33 percent compared to placebo.

“It gives me great joy that Radicava is now available in the U.S.,” Atsushi Fujimoto, president of Mitsubishi Tanabe Pharma America (MTPA), said in a press release. “After two decades without a new treatment, people with ALS finally have access to a new clinically meaningful treatment option for this horrible, progressive and incurable disease.”

MTPA’s Japanese parent company began researching and developing the drug in 2001 through a comprehensive clinical platform. Japanese and South Korean authorities approved edaravone to treat ALS in 2015.

“After 13 years of clinical research and investment, we have reached a seminal moment, which may shift the treatment paradigm for this terrible disease,” said Tom Larson, MTPA’s chief commercial officer. “As of today, all across the country, conversations between ALS specialists and patients may be substantially different.”

Between 12,000 and 15,000 Americans have ALS, with 5,000 to 6,000 new cases diagnosed annually, according to the Centers for Disease Control and Prevention. ALS progressively attacks and kills nerve cells in the brain and spinal cord that control voluntary muscle movements such as chewing, walking, breathin, and talking. These nerves lose the ability to activate specific muscles, resulting in muscle weakness and eventual paralysis.

“This new treatment may give hope to every person suffering from ALS, and we pray the positive result from this trial will set the tone for more therapies going forward. We all remain committed,” said Dr. Jonathan S. Katz, ALS clinical director at the California Pacific Medical Center in San Francisco.

Radicava is administered in 28-day cycles by intravenous infusion, a procedure that may be done at an ALS center, physician’s office, free-standing infusion center or hospital outpatient department. Home infusion providers can also offer the treatment, depending on individual health insurance and physician oversight.

Access to Radicava therapy is facilitated through Radicava Searchlight Support, which helps people who are prescribed the medication. A Searchlight Support care coordinator can help healthcare providers identify an infusion service site based on where patients live. Once the benefits investigation is completed, a case manager will contact the patient to explain benefits and available co-pay support options.

9 comments

  1. Iraj Farhad says:

    We live in Afghanistan my brother is diagnosed with ALS, can he get the edaravone here in Afghanistan? if yes how much does it cost??
    please please let me know

  2. Charlie says:

    “This new treatment may give hope to every person suffering from ALS,”

    No it won’t. Because doctors have already said that if you have had ALS for 15 months or more, you won’t benefit from it, and if you are allergic to sulphides you cannot take it as you risk death.

    “people with ALS finally have access to a new clinically meaningful treatment option …”
    Nope, not all.

  3. don ng says:

    Wonder this Radicava can help me suffering from bulbar mnd since late 2012 but excessive saliva and swallowing has only started since last year august so do you think it can help me tks

  4. Natalia says:

    Hopefully someone here can point us in the right direction for advise : my sister was diagnosed with ALS early this year (but symptoms started over 18 months ago ). She has started the treatment with Radicava (has now had 2 rounds ). As we live in West Africa there are no doctors here with relevant experience treating ALS and particularly with radicava – they can only help following instructions to deliver the medicine. Now, every time she gets worse during the 2-week treatment (with severe side effects that partially dissipate during the 2 week rest period ). She doesn’t want to continue – so the questions are: 1) are side effects (such as respiratory problems, gait/equilibrium affected and increased rigidity in limbs ) expected even though the medicine maybe working? And 2) if severe side effects outweight potential benefits, should she interrupt the treatment abruptly (as opposed to gradually decrease the dose )? Thank you

  5. Ahmad Nasim Khoshgowar says:

    Need for your kind aupport:
    A friend of mine was diagnosed with ALS almost a year ago though the symptoms had already started. He is 34 years old living in Afghanistan. Is that possible if he come to US for taking this new medicine and follow the procedure there?

  6. Rania rapti says:

    Hello everyone.I am from greece and my father was diagnosed with als in december 2016…the progress of the desease during these months is really fast….when i rode about radicava i thouhgt that it might help us but nobody hear knows about this drug…i wonder about the side effects and if it s worth the try…if anyone can help me please contact through e mail rania0709@yahoo.gr…thank u …

  7. Marie Thomas says:

    Well my husbands experience in trying to get drug has been horrible. Has doctor order, insurance and IV port already in since August 2nd. It is September 26th still no drug thanks to Searchlight and doctors office not knowing how to put us together with infusion cente.. One road block after another. In the mean time he is losing his speach and ability to swallow! I’ve never seen anything so poorly done.

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