VA Adds ALS Therapy Radicava ORS to National Formulary

The U.S. Department of Veterans Affairs National Formulary has added Radicava ORS (edaravone), an oral suspension to treat adults with amyotrophic lateral sclerosis (ALS)

Radicava ORS will have a national prior authorization process in place and will be available to U.S. veterans living with ALS who are within the VA's integrated healthcare system.

ALS is a rare disease that attacks and kills the nerve cells that control voluntary muscles. It is a progressive disease, and most cases will result in death from respiratory failure, usually within three to five years from when the symptoms first appear. About 5,000 people in the United States are diagnosed with ALS annually and about 29,000 people are currently living with ALS.

Radicava ORS, developed by Mitsubishi Tanabe Pharma America and approved in May 2022, is an orally administered version of Radicava, which was originally approved in 2017 as an intravenous infusion to treat ALS. The cost for Radicava ORS oral suspension (105 mg/5 mL) is around $13,403 for a supply of 50 milliliters, according to Drugs.com.

Mitsubishi Tanabe Pharma America recently announced 48-week results of an open-label phase 3 trial, which were published recently in Muscle & Nerve. The study enrolled 185 patients. The most common treatment-emergent adverse events (TEAEs) at week 48 were fall (22.2%), muscular weakness (21.1%) and constipation (17.8%). Serious TEAEs were reported by 25.9% of patients; the most common were worsening ALS symptoms, dysphagia, dyspnea, and respiratory failure. Forty-six (24.9%) patients reported TEAEs that were considered related to study drug; the most common were fatigue, dizziness, headache, and constipation. Sixteen (8.6%) patients discontinued study drug due to TEAEs.