Mitsubishi Tanabe Pharma America Announces More Than 10,000 People with ALS Treated with RADICAVA ORS® and/or RADICAVA®

Mitsubishi Tanabe Pharma America today announced that more than 10,000 people with amyotrophic lateral sclerosis (ALS) have received treatment with intravenous (IV) RADICAVA (edaravone) and/or RADICAVA ORS (edaravone) since the therapies became available in the U.S. in August 2017 and June 2022, respectively.1 To date, more than 2,000 U.S. HCPs have prescribed RADICAVA ORS and/or RADICAVA to one or more of their patients, and 79% of people who started treatment in the six-month period between June 1, 2022 and November 30, 2022 have continued treatment for three months or more through February.2,3 RADICAVA ORS and RADICAVA are widely distributed by specialty pharmacies across the U.S. and in Puerto Rico.

“This product milestone falls on MTPA’s seventh anniversary as a U.S. company committed to helping those with ALS,” said Atsushi Fujimoto, President, MTPA. “Addressing the unmet needs of people living with serious, debilitating diseases like ALS, is of the utmost importance to us, and we remain focused on delivering meaningful treatments to this community.”

RADICAVA ORS is an oral formulation that offers the same efficacy as RADICAVA and was shown in a pivotal trial to help slow the loss of physical function in ALS.4,5 To learn more about RADICAVA ORS, including information about dosing and administration, visit RADICAVA.com.

“As one of the first physicians to prescribe RADICAVA IV in 2017 and the oral formulation in 2022, this milestone holds significant meaning for me,” said Benjamin Rix Brooks, M.D., ALS specialist. “ALS is a devastating disease with no cure, but it’s reassuring to know that many living with the disease have received therapy with a treatment that may slow their disease progression.”

“I started receiving RADICAVA IV in 2017 when the therapy was approved by the FDA, and recently, I switched to the oral formulation before taking an RV trip with my family,” said Juan Reyes, U.S. Air Force Veteran living with ALS. “RADICAVA ORS offers me the flexibility to take my treatment on the road, instead of at an infusion center, and as an advocate and mentor to people living with ALS, I’m encouraged to know others have treatment options that may help them.”

The initial treatment cycle starts with daily dosing of RADICAVA ORS for 14 days followed by a 14-day drug-free period. Subsequent treatment cycles include daily dosing 10 out of 14 days followed by a 14-day drug-free period. People taking RADICAVA ORS should use the provided five milliliter syringe that comes with the product and should not use a household teaspoon to measure the medication. RADICAVA ORS should be stored upright at room temperature between 68°F-77°F and protected from light.4

In prior clinical trials for RADICAVA, the most common adverse events (AEs) reported in participants were contusion (15%), gait disturbance (13%) and headache (10%). 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.4 See Important Safety Information below.