Mitsubishi Tanabe Pharma America, Inc. (MTPA) is proud to announce that as of June 2022, RADICAVA ORS® (edaravone) has been added to the U.S. Department of Veterans Affairs National Formulary (VANF), with a national prior authorization process in place, making the treatment accessible to U.S. veterans living with amyotrophic lateral sclerosis (ALS) who are within the VA's integrated healthcare system.
RADICAVA ORS was approved by the U.S. Food and Drug Administration (FDA) on May 12, 2022 as an oral suspension form of edaravone that offers the same efficacy as the intravenous (IV) formulation, RADICAVA® (edaravone), and was shown in a pivotal trial to help slow the loss of physical function in ALS.1 To learn more about RADICAVA ORS, visit RADICAVA.com.
"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," said Atsushi Fujimoto, President, MTPA. "MTPA is committed to helping U.S. veterans living with ALS have access to our treatments, and we applaud the VA for making RADICAVA ORS available as an option for them."
The VANF is a listing of drugs and supplies that must be made available for prescription at all VA facilities.2 The purpose of the VANF is to provide pharmaceutical products while assuring the portability and standardization of the pharmacy benefit to eligible veterans accepted by the VA for care.2 The VANF criteria follow the FDA's approved labeling, and all VA requests will be determined at the national level by a single team of experts, enabling consistency across the system. The Criteria for Use of RADICAVA ORS can be found at the VA website here: https://www.pbm.va.gov/apps/VANationalFormulary/.
"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. military veteran living 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."
In prior clinical trials for RADICAVA, the most common adverse events (AEs) reported in participants were contusion (15%), gait disturbance (13%) and headache (10%).1 In the pivotal safety trial for RADICAVA ORS (MT-1186-A01), the most common AEs reported at 24 weeks in participants were muscular weakness (16.2%), fall (15.7%) and fatigue ( 7.6%). RADICAVA and RADICAVA ORS are contraindicated in people with a history of hypersensitivity to edaravone or any of the inactive ingredients.1 See Important Safety Information below.
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