The FDA just approved the first drug in 22 years to treat ALS — the second treatment ever for the disease. Edaravone (brand name Radicava) is an antioxidant drug thought to preserve motor neurons in people with ALS, allowing the nerves to keep their muscles working for a longer period of time.
The FDA approved Radicava less than a year after Mitsubishi Tanabe Pharma Corporation submitted a New Drug Application. The only other approved treatment specifically for ALS, riluzole, was approved in 1995. Edaravone was originally approved in Japan to treat stroke and in 2015, it was approved for use as a treatment for ALS in Japan and South Korea. According to MT Pharma, the drug has been demonstrated to slow decline of physical function in ALS patients by 33 percent.
Participants taking Radicava declined by approximately 5 points on the ALS Functional Rating Scale Revised (ALSFRS-R) over 24 weeks, whereas those who took the placebo declined by 7.5 points. The ALSFRS-R is a scale that enables physicians to evaluate an ALS patient’s degree of functional impairment with regard to activities such as walking, climbing stairs, swallowing, eating independently, dressing and speaking clearly.