Mitsubishi Tanabe Pharma America Announces Initiation of Postmarketing Commitment Study Assessing Daily Dosing of Oral Edaravone in Patients with ALS

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Mitsubishi Tanabe Pharma America, Inc.

Dec 14, 2020, 09:00 ET

JERSEY CITY, N.J., Dec. 14, 2020 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced the initiation of a global clinical study exploring daily dosing of an investigational oral formulation of edaravone (MT-1186) in patients with amyotrophic lateral sclerosis (ALS). The study, sponsored by Mitsubishi Tanabe Pharma Development America, Inc. (MTDA), is the postmarketing commitment following the U.S. Food and Drug Administration (FDA) approval of RADICAVA^® (edaravone) IV.

"We are excited to have the opportunity to further investigate the efficacy and safety of edaravone with daily dosing compared to an on/off dosing regimen," said Atsushi Fujimoto, President, MTPA. "Our researchers look forward to the investigation of an alternative dosing regimen in addition to our continual investment in conducting clinical studies that deepen our understanding of edaravone and to identify potential treatment options for ALS patients."

The global, multicenter, randomized, double-blind study, MT-1186-A02, will compare two dosing regimens for oral edaravone in approximately 380 people with ALS. The study's primary endpoint will measure change in ALS Functional Rating Scale-Revised (ALSFRS-R) score from baseline to Week 48 of treatment. After a screening period of eight weeks, participants (18 to 75 years of age) will receive either oral edaravone administered once daily or oral edaravone following the current regimen of FDA-approved RADICAVA IV, which is an on/off dosing regimen during each 28-day cycle.

Secondary endpoints for the study include change in respiratory function slow vital capacity (SVC) and ALS Assessment Questionnaire (ALSAQ-40), as well as change in ALSFRS-R and percentage change of forced vital capacity (FVC). In addition, time (days) to tracheostomy, permanent assisted mechanical ventilation or death will be measured, along with safety.

"As a provider of care to people with ALS, I am honored to be a part of this important research," said Gary Pattee, M.D., a principal investigator in the study. "It is critical that we continue to advance our understanding of this debilitating disease and further explore potential treatment options for the ALS community."

About MT-1186
MT-1186 is an investigational oral formulation of edaravone being studied in patients with amyotrophic lateral sclerosis (ALS). Edaravone was discovered and developed by researchers together with Mitsubishi Tanabe Pharma Corporation (MTPC), headquartered in Osaka, Japan. In May 2019, MTP group companies completed a series of Phase 1 studies administering the oral suspension and intravenous formulations of edaravone in healthy volunteers. MTDA has other oral edaravone studies in development. More information is available at ClinicalTrials.gov (NCT04165824 and NCT04577404).

Postmarketing Commitment Study
The MT-1186-A02 postmarketing commitment study is not planned to be included with the initial New Drug Application (NDA) submission for orally administered edaravone. More information on the study is available at ClinicalTrials.gov (NCT04569084).

About RADICAVA^® (edaravone) IV
The U.S. Food and Drug Administration (FDA) approved RADICAVA^® (edaravone) IV on May 5, 2017, as a treatment for amyotrophic lateral sclerosis (ALS).¹ 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. MTPC group companies began researching ALS in 2001 through an iterative clinical platform over a 13-year period. In 2015, edaravone IV was approved for use as a treatment for ALS in Japan and South Korea. Marketing authorization was granted in Canada in October 2018 and Switzerland in January 2019.

IMPORTANT SAFETY INFORMATION
Before you receive RADICAVA, tell your healthcare provider about all of your medical conditions, including if you:

have asthma.
are allergic to other medicines.
are pregnant or plan to become pregnant. It is not known if RADICAVA will harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if RADICAVA passes into your breast milk. You and your healthcare provider should decide if you will receive RADICAVA or breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of RADICAVA?

RADICAVA may cause serious side effects including hypersensitivity (allergic) reactions and sulfite allergic reactions.
Hypersensitivity reactions have happened in people receiving RADICAVA and can happen after your infusion is finished.
RADICAVA contains sodium bisulfite, a sulfite that may cause a type of allergic reaction that can be serious and life-threatening. Sodium bisulfite can also cause less severe asthma episodes in certain people. Sulfite sensitivity can happen more often in people who have asthma than in people who do not have asthma.
Tell your healthcare provider right away or go to the nearest emergency room if you have any of the following symptoms: hives; swelling of the lips, tongue, or face; fainting; breathing problems; wheezing; trouble swallowing; dizziness; itching; or an asthma attack (in people with asthma).
Your healthcare provider will monitor you during treatment to watch for signs and symptoms of all the serious side effects.

The most common side effects of RADICAVA include bruising (contusion), problems walking (gait disturbance), and headache.

These are not all the possible side effects of RADICAVA. Call your healthcare provider for medical advice about side effects. You may report side effects to Mitsubishi Tanabe Pharma America, Inc. at 1-888-292-0058 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

For more information, including full Prescribing Information and Patient Information regarding RADICAVA, 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. MTDA is dedicated to research and develop innovative pharmaceutical products that address the unmet medical needs of patients. For more information, please visit https://mt-pharma-development-america.com/.

Overview of Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma, which was founded in 1678, has its headquarters in Doshomachi, Osaka, which is the birthplace of Japan's pharmaceutical industry. With business centered on ethical pharmaceuticals, Mitsubishi Tanabe Pharma is a well-established company with one of the longest histories of pharmaceutical companies in Japan.² In accordance with the corporate philosophy of "contributing to the healthier lives of people around the world through the creation of pharmaceuticals," the Company formulated the key concept of Open Up the Future under the Medium-Term Management Plan 2016-2020. Through the discovery of drugs that address unmet medical needs, centered on its priority disease areas — immune-inflammation diseases, diabetes and kidney, central nervous system, and vaccines — Mitsubishi Tanabe Pharma will strive to contribute to the health of patients around the world. MTPC is the parent company of MTPA. For more information, go to https://www.mt-pharma.co.jp/e/.

Media inquiries:
Debbie Etchison
908-340-8578
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¹ RADICAVA^® U.S. Prescribing Information. August 2018.
^² Research by TOKYO SHOKO RESEARCH, LTD.

SOURCE Mitsubishi Tanabe Pharma America, Inc.