FDA nod for oral formulation of amyotrophic lateral sclerosis drug Radicava

The US Food and Drug Administration has approved Radicava ORS (edaravone) oral suspension for the treatment of adults with amyotrophic lateral sclerosis (ALS).

Developed by Japanese drugmaker Mitsubishi Tanabe Pharma, a part of Mitsubishi Chemical (TYO: 4188), Radicava ORS is an orally administered version of Radicava, which was originally  approved in 2017 as an intravenous (IV) infusion to treat ALS, commonly referred to as Lou Gehrig’s disease.  

Radicava ORS is self-administered and can be taken at home. After fasting overnight, Radicava ORS should be taken in the morning orally or through a feeding tube. The oral medication has the same dosing regimen as Radicava—an initial treatment cycle of daily dosing for 14 days, followed by a 14-day drug-free period and subsequent treatment cycles consisting of daily dosing for 10 out of 14-day periods, followed by 14-day drug-free periods.

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.