FDA Approves New Oral Medication for ALS

May 12, 2022

Radicava ORS® (edaravone – Mitsubishi Tanabe Pharma America), has received FDA approval to treat amyotrophic lateral sclerosis (ALS) in adults.

  • The product is a new oral suspension version of Radicava, a drug that first received FDA approval to treat ALS in 2017. Radicava is approved only for intravenous use.
  • Recommended dosing for Radicava ORS is 105mg (5mL) administered by mouth or via feeding tube. The medication is taken in the morning after overnight fasting. For one hour following administration, patients should consume no food and should only drink water.
  • Administration of both Radicava and Radicava ORS follows the following schedule:
    • Initial treatment cycle: Daily dosing for 14 days followed by a 14-day drug-free period.
    • Subsequent treatment cycles: Daily dosing for 10 days out of each 14-day period, followed by 14-day drug-free periods.
  • The wholesale acquisition cost of Radicava ORS is $12,719.30 per 28-day supply.
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