FDA has approved Radicava ORS (edaravone) oral suspension for the treatment of adults with amyotrophic lateral sclerosis (ALS). Radicava ORS is an orally administered version of Radicava, which was originally approved on 2017 as an intravenous (IV) infusion to treat ALS.
The effectiveness of Radicava ORS is based on a study that showed comparable levels of Radicava ORS in the bloodstream to the levels from the IV formulation of Radicava. The efficacy of Radicava for the treatment of ALS was previously demonstrated in a six-month clinical trial that served as the basis for approval in 2017. In that trial, 137 participants were randomized to receive Radicava or placebo. At Week 24, individuals receiving Radicava declined less on a clinical assessment of daily functioning compared to those receiving placebo.
The most common side effects of Radicava are bruising (contusions), problems walking (gait disturbances), and headaches. Fatigue is also a possible side effect from Radicava ORS. Radicava and Radicava ORS can have serious side effects associated with allergic reactions including hives, rash, and shortness of breath. For patients with sulfite sensitivity, sodium bisulfite—an ingredient in Radicava and Radicava ORS—could cause a type of allergic reaction that can be life-threatening.
FDA granted Radicava ORS Orphan Drug approval, Priority Review, and Fast Track designations.