We welcome the FDA’s approval Thursday of an oral formulation of the drug edaravone, produced by Mitsubishi Tanabe Pharma America (MTPA) to treat ALS.
An intravenous formulation of edaravone, Radicava, was first approved by the FDA in 2017. Clinical trials comparing the oral formulation to the intravenous formulation demonstrated that the two modes of administering edaravone are similarly safe. A phase 3 clinical trial testing long term safety and efficacy continues.
In a statement shared by MTPA when announcing the approval, ALS Association President and CEO Calaneet Balas said:
"To address the unmet needs in ALS, we must continue to find new treatments, as well as optimize current treatments and care. We thank MTPA and the FDA for working diligently to make this oral formulation possible and are confident it will be a welcome addition to help further support the ALS community."
The intravenous formulation has not been accessible for some people with ALS due to its route of delivery. FDA’s decision approving the oral formulation will allow for greater ease of use and makes edaravone accessible to more people.