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ALS Worldwide
1800 North Prospect Avenue, Suite 4B
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ALS Worldwide
May 06, 2017

FDA Approval of Edaravone


*View ALS Worldwide Press Release on the FDA approval of Edaravone.

The anticipated FDA approval for Edaravone, also known as Radicava, has arrived a full month earlier than expected. On Friday afternoon, May 5, 2017, FDA authorization was granted to Mitsubishi Tanabe Pharma America, Inc. to manufacture and distribute this important medication that has already provided systemic benefit to many with ALS in Japan, India, and to smaller patient groups in at least 16 other countries, including the US.

At ALS Worldwide, we have had firsthand experience providing compassionate use of Edaravone to a group of ALS patients since August 2016. Because of the positive trial results shared by Mitsubishi Tanabe at that time, we felt it important to enable this medication, on a compassionate use basis, to those who sought Edaravone and were able to manage the challenges Edaravone encompasses. Some US and EU patients traveled individually to Japan to bring back a several-month supply for themselves. For others, we traveled abroad to import this medication for its compassionate use trial and benefits in the US and other countries.

We learned that the majority of those who began its use, now for as long as 10 months, have achieved benefits that outweigh some of the challenges involved in its administration. Edaravone, or Radicava, requires a PICC line or Port-A-Cath for daily intravenous (IV) injection and can take up to an hour for the daily infusion to be completed. For most, this was achieved in-home and soon became an acceptable part of their daily routine.

22 years after the introduction of Rilutek (generic name riluzole), we appear to have a new systemic treatment that offers important benefits to the ALS patient community. Radicava (as it is now named in the United States) is expected to be available to patients and their doctors as early as August 2017, but may be up to three months later.

In months past, ALS Worldwide has responded only to specific patient inquiries for individual compassionate usage of Edaravone, funded in whole or in part by patients and families themselves. Our role included sourcing and importing the medication, confirming its authenticity and safety, continuous monitoring of usage, and helping develop local medical oversight, administration of Edaravone, and correlation of patient usage and results. ALS Worldwide has provided like services for other trial medications under the supervision of our medical and scientific advisors, to whom we are deeply indebted. This is part of our ongoing effort to support the ALS patient community, as we have done since 2002.

What can you do now that Edaravone has been approved?

  1. In order to make an informed decision about the usage of Radicava, learn what is involved in procuring a PICC line or Port-A-Cath by reviewing this document: Stanford Hospital Patient Information
  2. Notify your local pharmacy that you wish to be informed as soon as Radicava becomes available
  3. Contact your insurance company concerning their coverage for Radicava
  4. Discuss the installation of the PICC line or Port-A-Cath with your local physician

FDA News Release

Mitsubishi Tanabe Pharma Corp news release of estimated infusion cost.

ALS Worldwide began informally in 2002, when our son Ben Byer was first diagnosed with sporadic ALS. Our efforts for Ben, and eventually thousands of other patients now in more than 125 countries around the world, has continued as a not-for-profit organization since 2008. 

Today, we strive to help people with ALS live better and longer lives by providing compassionate care and counseling, assistance in managing ALS symptoms, greater access to beneficial medications, information about medical devices and communication systems, caregiver support, and guidance on healthcare topics and resources.  

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