Radicava ORS

Two Canadian provinces — Prince Edward Island, and Newfoundland and Labrador — are covering the cost of the oral formulation of Radicava (edaravone) for eligible residents with amyotrophic lateral sclerosis (ALS). Patients will have access through their provincial drug plans to Radicava Oral Suspension, developed along with…

Mitsubishi Tanabe Pharma America (MTPA), which had been testing a once-daily regimen of its oral therapy Radicava ORS (edaravone) for amyotrophic lateral sclerosis (ALS), announced that it is discontinuing the Phase 3b trial and its extension study. That decision comes after an interim analysis by an independent…

A Phase 3b study evaluating the long-term safety and effectiveness of two dosing regimens of Radicava ORS (edaravone) — an approved oral formulation of the medicine — in people with amyotrophic lateral sclerosis (ALS) is now fully enrolled. The study was designed to fulfill a post-marketing commitment that…

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…

Note: This story was updated March 10, 2023, to correct a secondary headline to note the therapy was tracked for less than a year. The story also clarifies the timing of results from a Phase 3 clinical trial and that edaravone is believed to reduce oxidative stress. Radicava ORS, an…

Note: This story were updated Feb. 14, 2023, to correct that ICER analyses found both Radicava ORS and Relyvrio are not cost-effective for the treatment of ALS. The recently approved therapies Relyvrio (sodium phenylbutyrate and taurursodiol) and …

An oral suspension form of Radicava (edaravone), an approved treatment of amyotrophic lateral sclerosis (ALS), was favored for patient reimbursement in Canada by a branch of the Canadian Agency for Drugs and Technologies in Health (CADTH). The opinion issued by the CADTH Canadian Drug Expert Committee recommended that Radicava Oral…

Radicava Oral Suspension, an oral formulation of edaravone, has been approved in Canada for treating amyotrophic lateral sclerosis (ALS). Mitsubishi Tanabe Pharma Canada (MTP-CA), the subsidiary of Mitsubishi Tanabe Pharma America that markets Radicava in Canada, has announced plans to make the oral formula available to patients…

Nearly 2,000 amyotrophic lateral sclerosis (ALS) patients in the United States have been treated with Radicava ORS (edaravone) since the oral suspension formulation became available there in May, the therapy’s U.S. marketer, Mitsubishi Tanabe Pharma America (MTPA), announced. This formulation is seen to be as equally effective as Radicava, an…

Note: This story was updated Aug. 10, 2022, to clarify the U.S. Food and Drug Administration advisory committee voted there is no substantial evidence supporting AMX0035 efficacy. When added to standard of care, both the experimental oral therapy AMX0035 and the U.S.-approved Radicava ORS oral suspension provide comparable…