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FDA Approves Radicava (Edaravone) as Treatment for ALS

Posted: May 5, 2017 in Other News

ALS Therapy Development InstituteALS Therapy Development Institute

CAMBRIDGE, MA – The Food and Drug Administration announced it has granted approval to MT Pharma America to begin marketing Edaravone as a treatment for amyotrophic lateral sclerosis (ALS). The approval of Edaravone marks the first new treatment to be approved for ALS in the United States since Rilutek (Riluzole) was approved in 1995.

“This announcement is an important one. The approval gives people with ALS and their doctors a new treatment option to explore together. ALS is a complex disorder, and it will require multiple different approaches to bring relief to all those diagnosed with ALS. With several additional potential treatments in clinical trials today, this is a uniquely hopeful time for the ALS community,” said Steve Perrin, Ph.D., CEO & CSO of the ALS Therapy Development Institute (ALS TDI).

The ALS Therapy Development Institute will hold a public webinar in the coming days to discuss Edaravone with the ALS community. Advance registration required at www.als.net/als-webinars.

Key Highlights

  • Edaravone will be marketed as Radicava in the United States. Here is a link to the approved drug label from the FDA.
  • Edaravone was approved in Japan in June 2015. It was approved shortly thereafter in South Korea. It was approved by the FDA in the US in May 2017.
  • MT Pharma America filed for marketing approval in the US in August 2016 without conducting clinical trials in the US first. This is a very unique path to approval as it has been historically uncommon for the FDA to accept applications without US clinical trial data.
  • Edaravone is delivered via intravenous infusion 10-14 days at a time followed by a drug holiday of similar length.
  • MT Pharma America aims to have Radicava available for use in the US by August 2017.
  • People with ALS looking to learn more should visit www.mt-pharma-america.com or www.radicava.com.

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