Saturday, 22 July 2017

USFDA approves first new ALS treatment

09 May 2017 | News

Edaravone (MCI-186) is described as a free radical scavenger that is believed to relieve the effects of oxidative stress, a likely factor in the onset and progression of ALS

USFDA has finally approved MT Pharma America’s Radicav opening the door to the first new therapy for amyotrophic lateral sclerosis (ALS) in more than 20 years.

Edaravone (MCI-186) is described as a free radical scavenger that is believed to relieve the effects of oxidative stress, a likely factor in the onset and progression of ALS.

The drug’s approval was based on Phase III trials showing that people given Radicava showed significantly less decline - by 33 percent - in physical function compared to placebo as measured by the ALS Functional Rating Scale-Revised (ALSFRS-R), the firm noted.

According to the company, edaravone will be available for distribution to U.S. ALS centers in August of 2017. The company says it will cost almost $146,000 each year, compared with a $35,000 price tag in Japan.

Gwyneth Dickey Zakaib, company representative said, “added cost reflects investments in infrastructure and research and development the company has made in order to gain approval and market the drug in the United States."

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