May 13, 2022
New Japan-originated ALS treatment option available to patients in the U.S.
FDA approval of RADICAVA ORS® 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 U.S. Food and Drug Administration (FDA) has
approved RADICAVA ORS® (edaravone) for the treatment of amyotrophic lateralsclerosis (ALS) on May 12, 2022.
RADICAVA ORS® is an oral suspension formulation that contains the same active
ingredient as edaravone for intravenous infusion (Japanese product name: Radicut®
Injection 30 mg and Radicut® Bag for I.V. Infusion 30 mg) for ALS treatment and being
developed globally, primarily by Mitsubishi Tanabe Pharma Development America, Inc.
The route of administration of edaravone is limited to intravenous infusion so far. With
the approval of RADICAVA ORS®, ALS patients have flexibility in how they take their
medicine.
RADICAVA ORS® is specifically formulated for patients with ALS and provides a flexible
administration option with a small, 5 mL dose (taken orally or via feeding tube), a portablebottle, an oral dosing syringe and no need for refrigeration or reconstitution.
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 has already filed this drug in Japan and Switzerland.

Mitsubishi Chemical Holdings Group
Corporate Communications Div.
Osaka Corporate Communications Dept.
Media contacts: [+81] (0)6-6205-5119

1 / 2■ About RADICAVA ORS® (edaravone)
RADICAVA ORS® is an investigational oral suspension of edaravone being studied in patientswith amyotrophic lateral sclerosis (ALS) by Mitsubishi Tanabe Pharma Corporation (MTPC).
RADICAVA ORS® received Fast Track designation from the FDA in October 2019. One cycleof administration of RADICAVA ORS® is a total of 28 days, including both the dosing
period and the drug-free period, and that cycle is repeated. The first cycle has a dosing
period of 14 consecutive days of administration followed by a drug-free period of 14 days.
In subsequent cycles, patients receive daily dosing for 10 days within a 14-day dosingperiod, followed by a 14-day drug-free period. RADICAVA ORS® needs to be refrigerated
during the distribution process and in pharmacies, but patients can keep it at room
temperature.
■ 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®.
One cycle of administration of RADICAVA® is a total of 28 days, including both the dosing
period and the drug-free period, and that cycle is repeated. Adults receive 60 mg ofRADICAVA® intravenously for 60 minutes once per day. The first cycle has a dosing
period of 14 consecutive days of administration followed by a drug-free period of 14 days.
In subsequent cycles, patients receive daily infusions for 10 days within a 14-day dosing
period, followed by a 14-day drug-free period. The indication of ALS has been approvedin 9 countries including Japan in June, South Korea in December 2015, the United Statesin May 2017, Canada in October 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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