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www.fdanews.com/articles/178216-fda-to-review-mitsubishis-nda-for-als-treatment

FDA to Review Mitsubishi’s NDA for ALS Treatment

September 1, 2016

The FDA has accepted the NDA for Mitsubishi’s edaravone drug, putting it on course to be the first approved treatment for amyotrophic lateral sclerosis (ALS) in more than 20 years.

A decision on the drug is not expected until summer 2017. If approved, the medicine would be commercialized under the brand name Radicava, through the newly formed MT Pharma America.

The edaravone NDA has been supported by a research program in Japan and has been approved for use in that country, as well as in South Korea. Last year, edaravone was granted an Orphan Drug Designation by the FDA and the European Commission.

Edaravone works as an antioxidant and scavenges free radicals, protecting against oxidative stress and neuronalapoptosis.

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