ALS TDI statement regarding FDA marketing approval of Radicava (Edaravone) as a treatment for ALS.
The Food and Drug Administration announced today 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 http://www.als.net/als-webinars/.
- 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
ALS is a progressive and fatal neurodegenerative disease. Most people diagnosed with ALS will survive only 3-5 years. Every 90 minutes someone in the United States is diagnosed with ALS, and approximately 30,000 people in the United States are living with ALS at any given moment. Some forms of ALS are genetic, linked to dozens of different genes associated with the disease. However, most ALS cases are still considered sporadic, having developed without a known genetic link. For these reasons and others, ALS remains a challenging heterogeneous disease, with many different forms and highly variable progression rates between each individual person diagnosed.
Edaravone was developed by Mitsubishi Tanabe Pharma Corporation in Japan, originally as a treatment used in the recovery from stroke. Later, the company worked through several clinical trials in Japan to explore its potential as a treatment for ALS given its properties as a free radical scavenger. Japan’s pharmaceutical regulatory agency approved edaravone to be marketed as a treatment for ALS in 2015. In Japan edaravone is marketed as Radicut, whereas in the United States it will be marketed by MT Pharma America as Radicava following the FDA approved issued today.
People with ALS should refer to the MT Pharma America website (www.mt-pharma-america.com) for more information about edaravone. 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 http://www.als.net/als-webinars/.