Radicut oral suspension 2.1% approved in Japan to treat amyotrophic lateral sclerosis.- Mitsubishi Tanabe Pharma Corporation.
Mitsubishi Tanabe Pharma Corporation, a member of the Mitsubishi Chemical Group, announced that MTPC obtained the regulatory approval of Radicut Oral Suspension 2.1% (generic name: edaravone) for the treatment of patients with amyotrophic lateral sclerosis (ALS) from the Ministry of Health, Labour and Welfare on December 23, 2022.
Radicut Oral Suspension 2.1% 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 the treatment of ALS. Radicut Oral Suspension 2.1% is specifically formulated for patients with ALS and provides 5 mL dose, an oral dosing syringe once a day.
Prior to this approval, edaravone is solely administered via intravenous infusion in Japan. MTPC Group continues working tirelessly to develop the oral suspension formulation as a new treatment option for ALS patients in order to reduce the burden on ALS patients such as injection pain and outpatient visits.
In the U.S., where the same oral suspension formulation of edaravone (U.S. product name: Radicava ORS) was approved on May 12, 2022, Radicava ORS has been highly evaluated for its benefits of reducing burdens associated with conventional injections and enabling oral and tube administration.
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