Breaking News: FDA Approves Oral Edaravone

Emily Cerbone Foundation Blog, Home Page, In the News

This story has been updated with a link to the informational webinar about the new medication.

The U.S. Food and Drug Administration has approved RADICAVA ORS®, an oral form of edaravone that reports the same efficacy as RADICAVA® for intravenous infusion. This new formulation, which can be taken orally or via feeding tube, will help people living with ALS reduce injection pain and the amount of time it takes administer medication.

RADICAVA® is the only FDA-approved treatment option for ALS shown to slow the loss of physical function, as measured by the ALS Functional Rating Scale–Revised (ALSFRS-R). It was originally approved for the treatment of ALS in 2017.

“This is very welcome news,” said Andrea Pauls Backman, CEO of the Les Turner ALS Foundation. “Being able to take edaravone orally will make administration significantly more convenient and less burdensome for people living with ALS. We’re grateful to the clinical trial participants, Mitsubishi Tanabe Pharma America and all of the researchers who made this advancement possible.”

The Les Turner ALS Center at Northwestern Medicine was involved in the oral edaravone clinical trials. Offering access to enrollment in multiple clinical trials and with dedicated clinical trial coordinators, the Lois Insolia ALS Clinic at the Les Turner ALS Center is Chicagoland’s first and largest multidisciplinary ALS clinic. It provides access to the highest number of neurologists and dedicated pulmonologists in the Midwest as well as coordinated support and expertise at no cost from the Les Turner ALS Foundation.

Mitsubishi Tanabe Pharma America will host a webinar on Wednesday, May 18, at 1:00 p.m. CST to provide information on ALS and treatment options. Register online to watch the webinar.

Decisions regarding medication should be made in consultation with your doctor and should be part of a comprehensive treatment approach. More information on RADICAVA and RADICAVA ORS is available online.