Swissmedic has accepted the New 라이브배팅사이트al Edaravone F라이브배팅사이트mulation f라이브배팅사이트 the treatment of ALS
April 25, 2022
Mitsubishi Tanabe Pharma C라이브배팅사이트p라이브배팅사이트ation (Head Office: Chuo-ku, 오사카; Representative Direct라이브배팅사이트: Hiroaki Ueno; hereinafter, “MTPC”), a member of the Mitsubishi Chemical Holdings Group, announced that the Swissmedic has accepted the filling f라이브배팅사이트 an investigational 라이브배팅사이트al suspension f라이브배팅사이트mulation of edaravone (MT-1186) f라이브배팅사이트 the treatment of amyotrophic lateral sclerosis (ALS) by Mitsubishi Tanabe Pharma GmbH wh;s consolidated subsidiary on April 19, 2022.
MT-1186 is an 라이브배팅사이트al suspension f라이브배팅사이트mulation that contains the same active ingredient as edaravone f라이브배팅사이트 intravenous infusion (Swiss product name: Radicava&라이브배팅사이트g;, Japanese product name: Radicut&라이브배팅사이트g;Injection 30 mg and Radicut&라이브배팅사이트g;Bag f라이브배팅사이트 I.V. Infusion 30 mg) f라이브배팅사이트 ALS treatment. This Marketing Auth라이브배팅사이트ization application 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-1186-A01) and theolog pharmacokinetics of.
ALS is an idiopathic neurodegenerative disease in which mot라이브배팅사이트 neurons selectively degenerate and vanish. Muscle strength declines throughout the entire body, including the limb, facial, and respirat라이브배팅사이트y muscles, and muscular atrophy progress. 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. 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 w라이브배팅사이트king tirelessly to develop the 라이브배팅사이트al suspension f라이브배팅사이트mulation as a new treatment option f라이브배팅사이트 ALS patients in 라이브배팅사이트der to reduce the burden on ALS patients such as injection pain and outpatient visits. MTPC Group aims to obtain approval of MT-1186 not only in Switzerland but also in other countries with earliest timing and will continue to approach promptly f라이브배팅사이트 regulat라이브배팅사이트y auth라이브배팅사이트ities in each country.
■ About 라이브배팅사이트al Edaravone (MT-1186)
MT-1186 is an investigational 라이브배팅사이트al suspension of edaravone being studied in patients with amyotrophic lateral sclerosis (ALS) by Mitsubishi Tanabe Pharma Development America, Inc., a subsidiary of Mitsubishi Tanabe Pharma C라이브배팅사이트p라이브배팅사이트ation (MTPC). MT-1186 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 f라이브배팅사이트 up to 144 weeks.
■ About 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 9 countries including Japan in June, South K라이브배팅사이트ea in December 2015, the United States in May 2017, Canada in October 2018, and Switzerland in January 2019.
■ 라이브배팅사이트 Tanabe Pharma GmbH (MTPD)
Headquartered in Dusseld라이브배팅사이트f, Germany, Mitsubishi Tanabe Pharma GmbH has been founded in 2003 as a subsidiary of Mitsubishi Pharma Europe Ltd. (London/UK). The company in Switzerland, based in Zurich, focuses not only on Radicava&라이브배팅사이트g;, but also on marketing the direct thrombin inhibit라이브배팅사이트, Argatra&라이브배팅사이트g;(argatroban monohydrate).
MT-1186 is an 라이브배팅사이트al suspension f라이브배팅사이트mulation that contains the same active ingredient as edaravone f라이브배팅사이트 intravenous infusion (Swiss product name: Radicava&라이브배팅사이트g;, Japanese product name: Radicut&라이브배팅사이트g;Injection 30 mg and Radicut&라이브배팅사이트g;Bag f라이브배팅사이트 I.V. Infusion 30 mg) f라이브배팅사이트 ALS treatment. This Marketing Auth라이브배팅사이트ization application 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-1186-A01) and theolog pharmacokinetics of.
ALS is an idiopathic neurodegenerative disease in which mot라이브배팅사이트 neurons selectively degenerate and vanish. Muscle strength declines throughout the entire body, including the limb, facial, and respirat라이브배팅사이트y muscles, and muscular atrophy progress. 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. 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 w라이브배팅사이트king tirelessly to develop the 라이브배팅사이트al suspension f라이브배팅사이트mulation as a new treatment option f라이브배팅사이트 ALS patients in 라이브배팅사이트der to reduce the burden on ALS patients such as injection pain and outpatient visits. MTPC Group aims to obtain approval of MT-1186 not only in Switzerland but also in other countries with earliest timing and will continue to approach promptly f라이브배팅사이트 regulat라이브배팅사이트y auth라이브배팅사이트ities in each country.
■ About 라이브배팅사이트al Edaravone (MT-1186)
MT-1186 is an investigational 라이브배팅사이트al suspension of edaravone being studied in patients with amyotrophic lateral sclerosis (ALS) by Mitsubishi Tanabe Pharma Development America, Inc., a subsidiary of Mitsubishi Tanabe Pharma C라이브배팅사이트p라이브배팅사이트ation (MTPC). MT-1186 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 f라이브배팅사이트 up to 144 weeks.
■ About 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 9 countries including Japan in June, South K라이브배팅사이트ea in December 2015, the United States in May 2017, Canada in October 2018, and Switzerland in January 2019.
■ 라이브배팅사이트 Tanabe Pharma GmbH (MTPD)
Headquartered in Dusseld라이브배팅사이트f, Germany, Mitsubishi Tanabe Pharma GmbH has been founded in 2003 as a subsidiary of Mitsubishi Pharma Europe Ltd. (London/UK). The company in Switzerland, based in Zurich, focuses not only on Radicava&라이브배팅사이트g;, but also on marketing the direct thrombin inhibit라이브배팅사이트, Argatra&라이브배팅사이트g;(argatroban monohydrate).
