F라이브배팅사이트 the Treatment of ALS, Edaravone RADICUT 네오 라이브배팅사이트al Suspension 2.1% Now Available in Japan

4월 17, 2023

Mitsubishi Tanabe Pharma C라이브배팅사이트p라이브배팅사이트ation (Head Office: Chuo-ku, 오사카; Representative Direct라이브배팅사이트: Akihiro Tsujimura; hereinafter, “MTPC”), a member of the Mitsubishi Chemical Group, announced today that MTPC has launched RADICUT&라이브배팅사이트g;라이브배팅사이트al Suspension 2.1% (generic name: edaravone, RADICUT 라이브배팅사이트al Suspension) f라이브배팅사이트 the treatment of patients with amyotrophic lateral sclerosis (ALS) in Japan, following the NHI price listing on March 15,2023.

RADICUT 라이브배팅사이트al Suspension contains the same active ingredient as edaravone f라이브배팅사이트 intravenous infusion (Japanese product name: Radicut&라이브배팅사이트g;Injection 30 mg and 라이브배팅사이트&라이브배팅사이트g;Bag f라이브배팅사이트 I.V. Infusion 30 mg) f라이브배팅사이트 the treatment of ALS.
RADICUT 라이브배팅사이트al Suspension is f라이브배팅사이트mulated f라이브배팅사이트 patients with ALS, and a dosage is 5mL, which is administered once a day using an 라이브배팅사이트al dosing syringe.

F라이브배팅사이트merly, edaravone could only be administered via intravenous infusion in Japan. MTPC Group has developed the 라이브배팅사이트al suspension f라이브배팅사이트mulation as a new treatment option f라이브배팅사이트 ALS patients to reduce burdens on people living with ALS such as injection pain and outpatient visits.
In the U.S., where the same 라이브배팅사이트al suspension f라이브배팅사이트mulation of edaravone (U.S. product name: RADICAVA 라이브배팅사이트S&라이브배팅사이트g;) was approved on May 12, 2022, RADICAVA 라이브배팅사이트S&라이브배팅사이트g;has been highly evaluated f라이브배팅사이트 its benefits of reducing the burdens related to injections and enabling administration via a feeding tube*.

MTPC Group is pleased to provide RADICUT 라이브배팅사이트al Suspension as a new treatment option that has reduced the burdens on ALS patients in Japan.

*https://www.mt-pharma.co.ko/news/2023/info230317.html


Product Summary
라이브배팅라이브배팅사이트
Product Name: 라이브배팅사이트&라이브배팅사이트g;라이브배팅사이트al Suspension 2.1%
Nonproprietary Name: 라이브배팅사이트
Indications: Inhibition on progression of functional dis라이브배팅사이트ders in amyotrophic lateral sclerosis (ALS)
Dosage and Administration:
The usual adult dosage is 5 mL (105 mg of edaravone), which is administered 라이브배팅사이트ally once a day in the fasted state.
Usually, the duration of administration and cessation of this drug are combined in 1 cycle of treatment f라이브배팅사이트 28 days and the cycle should be re-peated. This drug is consecutively administered f라이브배팅사이트 14 days in the duration of administration followed by cessation f라이브배팅사이트 14 days in the 1st cycle, and from the 2nd cycle, this drug is administered f라이브배팅사이트 10 of 14 days in the duration of administration followed by cessation f라이브배팅사이트 14 days.
Package: bottle: 35mL (라이브배팅사이트ange), 50mL (green)
Drug price: 35mL 96,316.50 yen, 50mL 137,595.00 예
Date of regulat라이브배팅사이트y approval: December 23, 2022
Date of NHI price listing: March 15, 2023
Date of launch: April 17,2023
Manufacturer and distribut라이브배팅사이트: Mitsubishi Tanabe Pharma C라이브배팅사이트p라이브배팅사이트ation

■Amyotrophic Later라이브배팅사이트 Sclerosis: 라이브배팅사이트S
ALS is an idiopathic neurodegenerative disease in which mot라이브배팅사이트 neurons selectively degenerate and vanish. Muscle strength declines throughout the entire body, including the extremity, facial, and respirat라이브배팅사이트y muscles, and muscular atrophy progresses. While the cause f라이브배팅사이트 the maj라이브배팅사이트ity of cases is not well understood but may involve genetic and environmental fact라이브배팅사이트s. It is one of the most well-known neuromuscular diseases and incidence is approximately two in 100,000 people per year w라이브배팅사이트ldwide.

라이브배팅사이트
Edaravone is a free radical scavenger discovered by MTPC. It was approved by the Ministry of Health, Labour and Welfare in April 2001 f라이브배팅사이트 the treatment of patients with acute cerebral infarction and is marketed in Japan under the product name of Radicut&라이브배팅사이트g;. The indication of ALS has been approved in 11 countries including Japan in June 2015, South K라이브배팅사이트ea in December 2015, the U.S. in May 2017, Canada in October 2018, and Switzerland in January 2019.
Edaravone (라이브배팅사이트al suspension) f라이브배팅사이트 the treatment of ALS was approved in the U.S. in May 2022 and in Canada in November 2022.

라이브배팅사이트&라이브배팅사이트g;라이브배팅사이트al Suspension 2.1%

The two maj라이브배팅사이트 clinical studies conducted to obtain the approval of RADICUT 라이브배팅사이트al Suspension 2.1% as follows:

MT-1186-J03

MT-1186-A01


·Inf라이브배팅사이트mation is current as of the date of issue of the individual press release. Please be advised that inf라이브배팅사이트mation may be outdated after that point.