Radicava ORS, oral form of edaravone, available to US veterans

Process in place to dispense ALS therapy via Veterans Affairs health system

Patricia Inácio, PhD avatar

by Patricia Inácio, PhD |

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Radicava ORS, an oral formulation of Radicava (edaravone), is now available to U.S. veterans living with amyotrophic lateral sclerosis (ALS), the therapy’s developer, Mitsubishi Tanabe Pharma America (MTPA), announced.

The therapy was added to the U.S. Department of Veterans Affairs National Formulary (VANF) in June 2022, shortly after its May approval by the U.S. Food and Drug Administration (FDA). This was an initial step in making Radicava ORS available to service members who are part of the Veterans Affairs’ (VA) integrated healthcare system.

Approval at the national level also is required for dispensing this medication, and that process now is “in place,” MTPA reported, making the treatment available to patients within the VA system.

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“Given the devastating nature of ALS and the demand for additional treatment options, we are thrilled to see Radicava ORS added to the VA’s National Formulary,” Atsushi Fujimoto, MTPA’s president, said in a company press release.

The VANF comprises a list of prescription medications and products available across all VA facilities. Its goal is to ensure a therapy is appropriate and safe for patient use, with criteria that follows the FDA’s approval label for a treatment.

“Some studies have shown that military veterans are twice as likely to develop ALS than those who haven’t served in the military,” said Juan Reyes, a U.S. veteran with ALS and patient ambassador for MTPA.

“The addition of Radicava ORS to the VA National Formulary symbolizes not only the dedication and recognition of veterans by MTPA and the VA, but also a significant step forward for those in the ALS community in need of an alternate treatment option,” Reyes added.

Radicava ORS is an oral formulation of edaravone, a medication that works to slow ALS progression by reducing oxidative damage to cells. Oxidative stress is believed to drive nerve cell death, as neurons are particularly sensitive to it.

FDA approval was based on data showing that Radicava ORS delivers similar amounts of edaravone to the body as the intravenous (into-the-vein) infusion formulation of Radicava, and seems to be equally effective at slowing disease progression.

As a therapy that can be self-administered at home, taken by mouth or via feeding tube, it can be more convenient and easier to use less than Radicava.

The oral therapy follows the same dosing regimen as the infusion treatment, with both administered in 28-day cycles. In a first treatment cycle, Radicava ORS is taken daily for 14 days, followed by 14 days without treatment. Subsequent treatment cycles consist of daily dosing for 10 of 14 consecutive days, followed by 14 days (two weeks) of no treatment.

Patients are advised to take Radicava ORS in the morning, after overnight fasting, and to not eat — drinking only water, if wanted — for one hour after the drug’s administration.

The oral formulation of edaravone is also approved in Canada, where it is sold as Radicava Oral Suspension, and Japan, where it is marketed as Radicut Oral Suspension 2.1%.