January 13, 2022

FDA Acceptance of New Drug Application
for Oral Edaravone Formulation for the Treatment of ALS
Mitsubishi Tanabe Pharma Corporation (MTPC, Head Office: Chuo-ku, Osaka;
President & Representative Director: Hiroaki Ueno) announced the U.S. Food andDrug Administration (FDA) has accepted the new drug application (NDA) for aninvestigational oral formulation of edaravone (MT-1186) for the treatment ofamyotrophic lateral sclerosis (ALS) by Mitsubishi Tanabe Pharma Development
America, Inc. (MTDA) which is MTPCʼs research and development subsidiary in theUS on January 11th.
The FDA has accepted the application for priority review with a Prescription Drug
User Fee Act (PDUFA) action date of May 12, 2022.
MT-1186 is an oral suspension formulation that contains the same active ingredientas edaravone for intravenous infusion (US product name: Radicava®, Japanese
product name: Radicut® Injection 30 mg and Radicut® Bag for I.V. Infusion 30 mg)

for ALS treatment.
This NDA was submitted based on both the 24-week results from the global Phase
3 study evaluating the safety and tolerability of investigational MT-1186 in the ALS(MT-1186A01)

andtheclinicalpharmacology

study

comparingthepharmacokinetics of MT-1186 and the injectable formulation (MT-1186 J03).
At this time, the route of administration of edaravone is limited to intravenous
infusion. MTPC Group will continue working tirelessly to develop the oral suspension
formulation as a new treatment option for ALS patients in order to reduce theburden on ALS patients such as injection pain and outpatient visits.
MTPC Group aims to obtain approval of MT-1186 not only in the U.S. but also inother countries with earliest timing and will continue to approach promptly forregulatory authorities in each country.
Mitsubishi Tanabe Pharma Corporation
Communication Crossroads Department
Media contacts: TEL: +81 6 6205 5119

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About Oral Edaravone (MT-1186)
MT-1186 is an investigational oral suspension of edaravone being studied in patientswith amyotrophic lateral sclerosis (ALS) by Mitsubishi Tanabe Pharma Development
America, Inc., a subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). MT1186 received Fast Track designation from the FDA in October 2019. The ongoing
MT-1186 A03 study is an extension study of up to 96 weeks of treatment in patients
who have completed MT-1186 A01. MT-1186-A01 and MT-1186 A03 studies
provide data for up to 144 weeks.
About Edaravone
Edaravone is a free radical scavenger discovered by MTPC. It was approved by theMinistry of Health, Labour and Welfare in April 2001 for the treatment of patientswith acute cerebral infarction and is marketed in Japan under the product name ofRadicut®. The indication of ALS has been approved in 9 countries including Japanin June, South Korea in December 2015, the United States in May 2017, Canada inOctober 2018, and Switzerland in January 2019.
About Mitsubishi Tanabe Pharma Development America, Inc.
The headquarter of Mitsubishi Tanabe Pharma Development America, Inc.
(MTDA) is located in Jersey City, New Jersey. MTDA is a wholly-owned subsidiaryof MTPC’s 100 percent-owned US holding company, Mitsubishi Tanabe Pharma
Holdings America, Inc. MTDA achieved the approval of Radicava for the first time inmore than 20 years in the U.S in the ALS treatment.
MTDAisdedicated to researching anddeveloping innovative

pharmaceuticalproducts that address the unmet medical needs of patients.
For more information, go to https://mt-pharma-development-america.com/

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