FDA approves oral ALS treatment
The FDA has approved Radicava ORS oral suspension for the treatment of adults with ALS.
Radicava (edaravone, Mitsubishi Tanabe Pharma) was originally approved in 2017 as a treatment for ALS via IV infusion, the FDA said in a press release.
Radicava ORS is taken orally in the morning after an overnight fast. As with the IV version, the dosing regimen is 14 days, followed by 14 days without treatment, daily doses for 10 of the next 14 days and then another 14-day drug-free period, the FDA explained in its release.
A study showed that the daily functioning of those taking Radicava ORS declined less on clinical assessment compared with those who received placebo, the FDA stated. The most common side effects include bruising, gait disturbances, headaches and fatigue.