Mitsubishi Tanabe Pharma America Celebrates One-Year Anniversary of RADICAVA ORS® (edaravone) Launch in the U.S.

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Mitsubishi Tanabe Pharma America, Inc.

Jun 15, 2023, 09:00 ET

JERSEY CITY, N.J., June 15, 2023 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the one-year launch anniversary of RADICAVA ORS^® (edaravone) in the U.S. Since becoming available in June 2022, RADICAVA ORS has been used to treat over 5,300 people living with amyotrophic lateral sclerosis (ALS).¹

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 RADICAVA^® (edaravone), an intravenous (IV) treatment that was shown in a pivotal trial to help slow the loss of physical function in ALS.^2,3

"Looking back at the past year following the U.S. launch of RADICAVA ORS, I am proud of what we have accomplished for the ALS community, including delivering this oral treatment option to thousands of people in need," said Yasutoshi Kawakami, President, MTPA. "I look forward to continuing this momentum in the years to come, further underscoring our unwavering commitment to those living with this devastating disease."

To date, more than 2,100 U.S. healthcare providers (HCPs) have prescribed RADICAVA ORS and/or RADICAVA to one or more of their patients, and 79% of people who started RADICAVA ORS treatment in the nine-month period between June 1, 2022 and February 28, 2023 have continued treatment for three months or more.^4,5 RADICAVA ORS and RADICAVA are widely distributed by specialty pharmacies across the U.S. and in Puerto Rico.

In addition to bringing RADICAVA ORS to market, MTPA continued to demonstrate its dedication to the ALS community with the following achievements:

Launching the JourneyMate Support Program™, which provides personalized answers and resources to help patients and caregivers on their ALS treatment journey. Experienced program team members are trained to address their educational needs for living with ALS to supplement what their doctor provides. For more information, call a JourneyMate Resource Specialist at 1-866-684-7737 or visit RADICAVA.com/journeymate.
Working with VA to have RADICAVA ORS 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 ALS who are within the VA's integrated healthcare system.
Continued to grow our body of knowledge around the use of edaravone in ALS with a breadth of data from real-world and clinical trials. This includes the publication of 48-week results from the global Phase 3 trial (MT-1186-A01) evaluating the long-term safety and efficacy of RADICAVA ORS in Muscle & Nerve, findings published in eClinicalMedicine from an administrative claims analysis that evaluated overall survival in U.S. patients with ALS treated with RADICAVA compared with those not treated with RADICAVA in a real-world setting, and an interim analysis of the Phase 4 REFINE-ALS study designed to identify predictive and pharmacodynamic biomarkers to measure the effect of RADICAVA in ALS, among other data.
Creation of the Share Your Story program, which shares the real-life experiences of those living with ALS and why treatment with RADICAVA ORS or RADICAVA IV 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.
Supporting those living with ALS via the Together We Fight platform, which encourages strength and empowerment among the ALS community through the sharing of real-life patient perspectives and disease resources. To learn more about the Together We Fight platform, visit TogetherWeFightALS.com

"The one-year anniversary of the launch of MTPA's RADICAVA ORS is a milestone that delivered an oral formulation option to people living with ALS that provides flexibility in treatment administration," said Laura Freveletti, CEO, Les Turner ALS Foundation. "We are eager to see RADICAVA ORS continue to make an impact on the ALS community."

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.⁶

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.² See Important Safety Information below.

About RADICAVA^® (edaravone) and RADICAVA ORS^® (edaravone)
The U.S. Food and Drug Administration (FDA) approved RADICAVA^® (edaravone) on May 5, 2017, and the oral formulation RADICAVA ORS^® (edaravone) on May 12, 2022, for the treatment of amyotrophic lateral sclerosis (ALS). RADICAVA is administered in 28-day cycles by IV infusion. It takes 60 minutes to receive each 60 mg dose. For the initial cycle, the treatment is infused daily for 14 consecutive days, followed by a two-week drug-free period. All cycles thereafter are infused daily for 10 days within a 14-day period, followed by a two-week drug-free period. 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. 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.²

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) and Malaysia (December 2021). 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 and RADICAVA ORS have been used to treat over 11,000 people with ALS, with over 1.4-million days of therapy, and have been prescribed by over 2,000 HCPs.^1,4,7

IMPORTANT SAFETY INFORMATION

Hypersensitivity Reactions
RADICAVA (edaravone) and RADICAVA ORS (edaravone) are 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 with RADICAVA.

Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue RADICAVA or RADICAVA ORS, treat per standard of care, and monitor until the condition resolves.

Sulfite Allergic Reactions
RADICAVA and 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-treated patients were contusion (15%), gait disturbance (13%), and headache (10%). In an open label study, fatigue was also observed in 7.6% of patients receiving RADICAVA ORS.

Pregnancy
Based on animal data, RADICAVA and 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 www.fda.gov/medwatch.

INDICATION
RADICAVA and RADICAVA ORS are indicated for the treatment of amyotrophic lateral sclerosis (ALS).

For more information, including full Prescribing Information, please visit www.RADICAVA.com.

About JourneyMate Support Program™
The JourneyMate Support Program™ offers educational support and resources for patients who are considering or have already been prescribed an MTPA product. An ALS Clinical Educator is an educational resource for patients who have been prescribed a Mitsubishi Tanabe Pharma America, Inc. (MTPA) product. An ALS Clinical Educator is provided by MTPA and VMS 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's (MTPC). It was established by MTPC to commercialize approved pharmaceutical products in North America. For more information, please visit www.mt-pharma-america.com or follow us on Twitter, Facebook and LinkedIn.

About Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation (MTPC), the pharma arm of Mitsubishi Chemical Group (MCG), is one of the oldest pharmaceutical companies in the world, founded in 1678. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. MCG has positioned health care as its strategic focus in its management policy, "Forging the future". 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 and additionally 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 https://www.mt-pharma.co.jp/e/.

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¹Data on file. Mitsubishi Tanabe Pharma America, Inc.
²RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022
³Edaravone (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
⁴Data on file. Mitsubishi Tanabe Pharma America, Inc.
⁵Data on file. Mitsubishi Tanabe Pharma America, Inc.
⁶RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022.
⁷Data on file. Mitsubishi Tanabe Pharma America, Inc.