April 25, 2022
Swissmedic has accepted the filling fora New Oral Edaravone Formulation for the treatment of ALS
Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation (Head Office: Chuo-ku, Osaka; Representative
Director: Hiroaki Ueno; hereinafter, “MTPC”), a member of the Mitsubishi ChemicalHoldings Group, announced that the Swissmedic has accepted the filling for aninvestigational oral suspension formulation of edaravone (MT-1186) for the treatment ofamyotrophic lateral sclerosis (ALS) by Mitsubishi Tanabe Pharma GmbH which is
MTPC’s consolidated subsidiary on April 19, 2022.
MT-1186 is an oral suspension formulation that contains the same active ingredient as
edaravone for intravenous infusion (Swiss product name: Radicava®, Japanese productname: Radicut® Injection 30 mg and Radicut® Bag for I.V. Infusion 30 mg) for ALS
treatment. This Marketing Authorization application was submitted based on both the 24week results from the global Phase 3 study evaluating the safety and tolerability ofinvestigational MT-1186 in the ALS (MT-1186-A01) and the clinical pharmacology study
comparing the pharmacokinetics of MT-1186 and the injectable formulation (MT-1186J03).
ALS is an idiopathic neurodegenerative disease in which motor neurons selectivelydegenerate and vanish. Muscle strength declines throughout the entire body, including
the limb, facial, and respiratory muscles, and muscular atrophy progress. While thecause for the majority of cases is not well understood but may involve genetic andenvironmental factors. It is one of the most well-known neuromuscular diseases andincidence is approximately two in 100,000 people per year worldwide. As many as 500
people are estimated to be affected by ALS in Switzerland.
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 the burden on ALS patientssuch as injection pain and outpatient visits. MTPC Group aims to obtain approval of MT1186 not only in Switzerland but also in other countries with earliest timing and willcontinue to approach promptly for regulatory authorities in each country.
Mitsubishi Chemical Holdings Group
Corporate Communications Div.
Osaka Corporate Communications Dept.
Media contacts: [+81] (0)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). MT-1186
received Fast Track designation from the FDA in October 2019. The ongoing MT-1186A03 study is an extension study of up to 96 weeks of treatment in patients who havecompleted 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 patients withacute cerebral infarction and is marketed in Japan under the product name of Radicut®.
The indication of ALS has been approved in 9 countries including Japan in June, South
Korea in December 2015, the United States in May 2017, Canada in October 2018, andSwitzerland in January 2019.
■ Mitsubishi Tanabe Pharma GmbH (MTPD)
Headquartered in Dusseldorf, Germany, Mitsubishi Tanabe Pharma GmbH has beenfounded in 2003 as a subsidiary of Mitsubishi Pharma Europe Ltd. (London/UK). The
company in Switzerland, based in Zurich, focuses not only on Radicava®, but also onmarketing the direct thrombin inhibitor, Argatra® (argatroban monohydrate).

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