The U.S. Food and Drug Administration (FDA) approved Radicava for the treatment of amyotrophic lateral sclerosis in 2017, two years after the medication gained its first approval in Japan and South Korea. The U.S. label was later expanded in 2022 to include an oral formulation of edaravone called Radicava ORS.
Radicava and Radicava ORS have both shown the ability to slow the progression of amyotrophic lateral sclerosis (ALS), as measured by slower declines in the ALS functional rating scale-revised over time. However, the medications cannot reverse damage that already has occurred nor reduce symptoms that are present at the time of treatment start.
Amyotrophic lateral sclerosis is a progressive condition with a widely variable disease course, so responses to any given medication also will vary from patient to patient. However, a clinical trial that supported Radicava’s approval found evidence of a slowing in disease progression compared with a placebo after about six months of treatment. Radicava also reduced worsening in quality of life over that period.
There is no known association between Radicava or Radicava ORS and alcohol. However, it is not known if it is safe to drink alcohol while taking these medications. It is recommended that patients discuss this matter with their healthcare providers.
Clinical trial data indicates that edaravone-based medications can slow functional decline in amyotrophic lateral sclerosis patients by about 33%. Yet, neither Radicava nor Radicava ORS can be considered cures for the disease. Albeit to a smaller extent, patients on these medications are still expected to experience disease progression and worsening disability.