JERSEY CITY, N.J., Feb. 27, 2023 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the publication of results from the global, multi-center, open-label, Phase 3 clinical trial (MT-1186-A01) evaluating the long-term safety and tolerability of RADICAVA ORS^® (edaravone) in the treatment of amyotrophic lateral sclerosis (ALS) over 48 weeks of treatment. Results from the study, which was completed in March 2022, showed RADICAVA ORS was generally well tolerated during the treatment period, with no new safety signals identified. Study findings were published in Muscle & Nerve.

"We're encouraged by the data that we continue to collect from the global Phase 3 trial of RADICAVA ORS, demonstrating a favorable safety profile after 48 weeks of treatment," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs at MTPA. "These data build upon the study's 24-week findings that supported the FDA approval of RADICAVA ORS and underscore our commitment to growing our body of knowledge regarding the use of this treatment in people with ALS."

RADICAVA ORS was approved by the U.S. Food and Drug Administration (FDA) on May 12, 2022, as an oral suspension form of edaravone, the active ingredient in RADICAVA^® (edaravone) – an FDA-approved intravenous (IV) treatment shown to slow the loss of physical function in ALS.¹ The approval of RADICAVA ORS was supported by several studies, including 24-week results from Study MT-1186-A01 demonstrating the safety and tolerability profile of the treatment in 185 ALS patients. 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 To learn more about RADICAVA ORS, visit RADICAVA.com. See Important Safety Information below.

Study MT-1186-A01 enrolled 185 patients with ALS across 50 sites in the in the U.S., Canada, Europe and Japan. The most common treatment-emergent adverse events (TEAEs) reported by ≥10% of participants at 48 weeks were fall (22.2%), muscular weakness (21.1%), constipation (17.8%), dyspnea (10.8%), dysphagia (10.3%) and back pain (10.3%). No serious TEAEs related to the study drug were reported during the 48-week study period. Additionally, the discontinuation rate during the treatment period was 25%, with 8.6% of participants discontinuing the drug due to TEAEs. Finally, a total of 12 deaths were reported due to 13 TEAEs (respiratory failure, worsening of ALS, pneumonia, acute respiratory failure, lung disorder, diabetic ketoacidosis, feeding disorder and suicide). None of the TEAEs leading to death were considered to be related to the study drug.

"The 48-week results from this trial suggest that RADICAVA ORS was well tolerated, and support its long-term use as a treatment for ALS," said Gary L. Pattee, M.D., a neurologist and ALS specialist based in Lincoln, Neb. "Our hope is for these data to provide additional information to physicians who are considering this oral treatment option for their patients."

This study was funded and conducted by MTPA and Mitsubishi Tanabe Pharma Development America, Inc. (MTDA).

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.¹

Edaravone was discovered and developed for ALS by Mitsubishi Tanabe Pharma Corporation (MTPC) and Mitsubishi Tanabe Pharma Development America, Inc. (MTDA), 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 in November 2022, 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 9,000 people with ALS, with over 1.2-million days of therapy, and have been prescribed by nearly 2,000 HCPs.^2-4

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 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) 100 percent owned U.S. holding company, Mitsubishi Tanabe Pharma Holdings America, Inc. 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 Development America, Inc.
The U.S. headquarters of Mitsubishi Tanabe Pharma Development America, Inc. (MTDA) is located in Jersey City, New Jersey. MTDA is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation's 100 percent-owned U.S. holding company, Mitsubishi Tanabe Pharma Holdings America, Inc. For more information, please visit https://mt-pharma-development-america.com/.

About Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation (MTPC), the pharma arm of the Mitsubishi Chemical Group, 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. The Mitsubishi Chemical Group 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 prioritizing work on "precision medicine" to provide drugs with high treatment satisfaction by identifying patient populations with high potential for efficacy and safety, focusing on the disease areas of central nervous system and immuno-inflammation. 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 https://www.mt-pharma.co.jp/e/.

Media inquiries:
Media_MTPA@mt-pharma-us.com

1. ^{RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022.}
2. ^{Data on file. Mitsubishi Tanabe Pharma America, Inc.}
3. ^{Data on file. Mitsubishi Tanabe Pharma America, Inc.}
4. ^{Data on file. Mitsubishi Tanabe Pharma America, Inc.}

SOURCE Mitsubishi Tanabe Pharma America, Inc.

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