Radicava is now available in the US – What does this mean for me?

For US patients and patients worldwide

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Radicut?
Yesterday Mitsubishi Tanabe Pharma America (MTPA) announced that Radicava™ (edaravone), a prescription medicine indicated for the treatment of amyotrophic lateral sclerosis (ALS) approved by the FDA on May 5, 2017, is now available in many parts of the United States.

The first ALS treatment to receive FDA approval in 22 years, the treatment has been shown in clinical trials to slow decline in the loss physical function.

 

I live in the US and have ALS. How can I access Radicava (edaravone)?

 

Edaravone requires a prescription from a physician. If you are interested in receiving this treatment, here are the steps to take as outlined by MTPA:

1. Chat with your physician about whether edaravone might be suitable for you. If it is, they’ll provide you with a prescription.

2. As soon as you receive a prescription, contact Searchlight Support by calling 844-SRCHLGT (844-772-4548). Searchlight Support is a program developed by MPTA to assist you with personal case management, reimbursement support, and once you start treatment, 24/7 product support. MPTA have created a program in which eligible patients may receive Radicava at no charge from MTPA while their insurance is assessing whether they will cover the cost of the medicine. MTPA have also created a program that provides Radicava at no charge if you do not have insurance and meet income and certain other requirements.

 

Can I still import edaravone into the US from Japan?

 

US patients are legally able to purchase and import medicines from overseas that have not yet been approved and/or are not yet available in the US. If you try to access Radicava in the US and find that it’s still not available to you for some reason in your specific location, you may still be able to import edaravone (Radicut) from Japan on a named patient individual import basis until Radicava is available in your region. For more information contact TheSocialMedwork on +31 20 808 4414. Your prescribing physician would need to state in writing that Radicava (edarvone) is not yet available in your region.

 

I don’t live in the US, Japan or South Korea. Can I still import edaravone into my country?

 

Yes! The FDA approval and availability of Radicava (edaravone) only affects US patients’ ability to import edaravone into the US. If you live outside the US you will still be able to import edaravone from Japan which was approved there under the name of Radicut over two years ago, via your country’s personal importation scheme.

 

What’s the difference between “Radicava” and “Radicut”?

 

Radicut and Radicava are simply different country brand names for the exact same active ingredient, edaravone, produced by the original manufacturer, Mitsubishi Tanabe Pharmaceuticals. Radicut is the brand name for the Japanese market, which was approved in Japan in 2015; Radicava is the brand name for the US market, which was approved by the FDA on May 5, 2017.

Radicava comes in the form of ready-to-use 30 mg/100 ml intravenous bags, making it easier for this medicine to be administered to patients who are treated at home.

Radicut was initially released in form of 30mg/ 20ml vials, which need to be diluted with saline and added to an intravenous bag before they can be administered. However Radicut is now also available in intravenous bags just like Radicava (also 30mg/100ml).

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Icon by Julie Collard from the Noun Project

 

For further information visit:

 

ALS association – Frequently Asked Questions About Radicava™ (edaravone)

Radicava by Mitsubishi Tanabe Pharma America

Accessing edaravone in your country by TheSocialMedwork

Radicut product information page – TheSocialMedwork





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DISCLAIMER: The Services of TheSocialMedwork do not replace a physician-patient relationship and are not intended as medical advice. TheSocialMedwork provides patients and physicians with existing treatment options abroad and creates access to these options after the patient and physician have made a professional decision. Privacy Policy / Terms and Conditions
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