FDA Approves Treatment for ALS

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

The treatment was originally approved as an intravenous infusion in 2017. This new form is to be self-administered orally or through a feeding tube in the morning following an overnight fast.

The dose regimen for both forms is the same; an initial cycle of daily dosing for 14 days, followed by 14 days without treatment. This is then followed by subsequent cycles of daily dosing for 10 days of a 14-day period, before another 14-day period without treatment. 

This approval follows a study that demonstrated comparative levels of the oral formulation in the bloodstream to that of the intravenous formulation.

Common adverse effects include contusions, gait disturbances, headaches, and fatigue. Both formulations of edaravone may cause allergic reactions in individuals with sulfite sensitivity and may be associated with adverse allergic reactions including hives, rash, and shortness of breath.

—Leigh Precopio

Reference:

FDA approves oral form for the treatment of adults with amyotrophic lateral sclerosis (ALS). News release. US Food and Drug Administration; May 12, 2022. Accessed May 19, 2022. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-oral-form-treatment-adults-amyotrophic-lateral-sclerosis-als