Edaravone

JERSEY CITY, N.J., June 23, 2025 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the three-year launch anniversary of RADICAVA ORS® (edaravone) in the U.S. Since its availability in June 2022, RADICAVA ORS has been used to treat over 13,519 people living with amyotrophic lateral sclerosis (ALS).1 "Reflecting on the past three years since the approval of RADICAVA ORS, I am encouraged by the progress we have made in providing a treatment for the thousands living with ALS in an oral formulation," said Yasutoshi Kawakami, President, MTPA. "We remain steadfast in driving forward research and scientific exchange to support those living with this devastating disease." Approved by the U.S. Food and Drug Administration (FDA) in May 2022, RADICAVA ORS is an oral formulation that offers the same efficacy as the previously available intravenous (IV) RADICAVA® (edaravone).2,3 The Phase 3 pivotal clinical trial showed treatment with RADICAVA (n=68) slowed the loss of physical function by 33 percent (approximately one-third) compared to those taking placebo (n=66) at 24 weeks, as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R).2,4 To date, more than 1,378 U.S. healthcare providers (HCPs) have prescribed RADICAVA ORS to one or more of their patients, and 82% of people who started RADICAVA ORS treatment in the 20-month period between June 20, 2022 and March 17, 2024 have continued treatment for three months or more.5,6 RADICAVA ORS is widely distributed by specialty pharmacies across the U.S. and in Puerto Rico. Over the past year, MTPA presented RADICAVA ORS data at 10 medical congresses around the world. This included original presentations at the 2024 European Network to Cure ALS (ENCALS) Meeting in Stockholm, Sweden, as well as seven RADICAVA ORS-focused presentations at the 23rd Annual Northeast Amyotrophic Lateral Sclerosis (NEALS) Meeting. For more information please visit: MTPA.com/Media. 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.2 In previous clinical trials of RADICAVA® (edaravone), the most common adverse events (AEs) reported in participants were contusion (15%), gait disturbance (13%) and headache (10%). In the pivotal open label 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 ORS is contraindicated in people with a history of hypersensitivity to edaravone or any of the inactive ingredients.2 See Important Safety Information below. MTPA is committed to supporting those taking RADICAVA ORS and their care partners through the JourneyMate Support Program™ and Share Your Story program . The JourneyMate Support Program™ gives patients the understanding, answers, and resources to help them move forward in their ALS journeys. Experienced program team members are trained to address their educational needs and provide them with personalized answers and resources for living with ALS. This program is here to supplement the resources their doctor provides. For more information, call a JourneyMate Resource Specialist at 1-866-684-7737 or visit RADICAVA.com/journeymate. The Share Your Story program shares the real-life experiences of those living with ALS and why treatment with RADICAVA ORS matters to them. Through the shared experiences of people living with ALS, the program aims to help people who live with the disease feel like they're part of a larger community of support and understanding, as people in the ALS community have a lot to share – questions and fears, as well as stories of courage and hope. To explore video and written experiences from people with ALS visit, ALSStories.com. About RADICAVA ORS® (edaravone) The U.S. Food and Drug Administration (FDA) approved RADICAVA ORS® (edaravone) on May 12, 2022, for the treatment of amyotrophic lateral sclerosis (ALS). In 2024, the FDA granted RADICAVA ORS Orphan Drug Exclusivity based on its major contribution to patient care by providing an oral suspension route of administration that avoids the burdens of IV administration. RADICAVA ORS is taken daily for 14 consecutive days followed by a 14-day drug-free period for the initial treatment cycle. For subsequent treatment cycles, RADICAVA ORS is taken for 10 days within a 14-day period followed by a 14-day drug-free period. Each 105 mg (5mL) dose of RADICAVA ORS should be taken in the morning after overnight fasting. Patients should not eat or drink (except water) within one hour after taking RADICAVA ORS.7 Edaravone was discovered and developed for ALS by Mitsubishi Tanabe Pharma Corporation (MTPC) and commercialized in the U.S. by Mitsubishi Tanabe Pharma America, Inc. (MTPA). The MTPC group companies began researching ALS in 2001 through an iterative clinical platform over a 13-year period. In 2015, edaravone was approved as RADICUT® for the treatment of ALS in Japan and South Korea. Marketing authorizations were subsequently granted in Canada (October 2018), Switzerland (January 2019), Indonesia (July 2020), Thailand (April 2021), Malaysia (December 2021), Australia (February 2023) and Brazil (February 2024). Marketing authorization for RADICAVA® Oral Suspension was granted in Canada (November 2022) and Switzerland (May 2023), and RADICUT® Oral Suspension 2.1% was granted regulatory approval in Japan in December 2022. To date, in the U.S., RADICAVA ORS, along with the previously available IV RADICAVA® (edaravone), have been used to treat over 19,000 people with ALS, with over 2.5-million days of therapy, and have been prescribed by over 2,600 HCPs.8-10 INDICATION RADICAVA ORS® (edaravone) is indicated for the treatment of amyotrophic lateral sclerosis (ALS). IMPORTANT SAFETY INFORMATION Hypersensitivity Reactions RADICAVA ORS® (edaravone) is contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients of this product. Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have occurred. Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue RADICAVA ORS, treat per standard of care, and monitor until the condition resolves. Sulfite Allergic Reactions RADICAVA ORS contain sodium bisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown but occurs more frequently in asthmatic people. Adverse Reactions The most common adverse reactions (≥10%) reported in RADICAVA® (edaravone)-treated patients and at least 2% more frequently than placebo were contusion (15% vs 9%), gait disturbance (13% vs 9%), and headache (10% vs 6%), respectively. In an open label study, fatigue was also observed in 7.6% of patients receiving RADICAVA ORS. Pregnancy Based on animal data, RADICAVA ORS may cause fetal harm. To report suspected adverse reactions or product complaints, contact Mitsubishi Tanabe Pharma America, Inc., at 1-888-292-0058. You may also report suspected adverse reactions to the FDA at 1-800-FDA-1088 or . Please see the full Prescribing Information, also available at . About JourneyMate Support Program™ The JourneyMate Support Program™ offers educational support and resources for patients who are considering or have already been prescribed a Mitsubishi Tanabe Pharma America, Inc. (MTPA) product. An ALS Clinical Educator is an educational resource for patients who have been prescribed an MTPA product. An ALS Clinical Educator is provided by MTPA and Momentum Life Sciences and is not affiliated with or provided by a doctor. An ALS Clinical Educator does not provide medical advice. The program does not provide medical advice and does not take the place of a patient's doctor. All questions about a condition, diagnosis, or treatment should be referred to the patient's doctor. If a patient has a medical emergency, they should call 911. Adverse events or product complaints should be reported by calling 1-888-292-0058. About Mitsubishi Tanabe Pharma America, Inc. Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). It was established by MTPC to develop and advance our pipeline as well as commercialize approved pharmaceutical products in North America. For more information, please visit or follow us on X (formerly Twitter), Facebook and LinkedIn. About Mitsubishi Tanabe Pharma Corporation Mitsubishi Tanabe Pharma Corporation (MTPC) is one of the oldest pharmaceutical companies in the world, founded in 1678, and focusing on ethical pharmaceuticals. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. MTPC sets the MISSION of "Creating hope for all facing illness". To that end, MTPC is working on the disease areas of central nervous system, immuno-inflammation, diabetes and kidney, and cancer. MTPC is focusing on "precision medicine" to provide drugs with high treatment satisfaction by identifying patient populations with high potential for efficacy and safety. In addition, MTPC is working to develop "around the pill solutions" to address specific patient concerns based on therapeutic medicine, including prevention of diseases, pre-symptomatic disease care, prevention of aggravation and prognosis. For more information, go to . Media inquiries: [email protected] 1 Data on file. Mitsubishi Tanabe Pharma America, Inc. 2 RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022 3 Edaravone (MCI-186) ALS 19 Study Group. Safety and efficacy of edaravone in well defined patients with amyotrophic lateral sclerosis: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2017;16(7):505-512 4 Shimizu H, et al. Bioequivalence study of oral suspension and intravenous formulation of edaravone in healthy adult subjects. Clin Pharmacol Drug Dev. 2021;10(10):1188-1197. 5 Data on file. Mitsubishi Tanabe Pharma America, Inc. 6 Data on file. Mitsubishi Tanabe Pharma America, Inc. 7 RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022 8 Data on file. Mitsubishi Tanabe Pharma America, Inc. 9 Data on file. Mitsubishi Tanabe Pharma America, Inc. 10 Data on file. Mitsubishi Tanabe Pharma America, Inc. SOURCE Mitsubishi Tanabe Pharma America WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED