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FDA approves first ALS/Lou Gehrig's disease therapy in 22 years

Published on 18/05/17 at 10:42am

The FDA has announced that it has approved Mitsubishi Tanabe Pharma’s Radicava (edaravone) for the treatment of amyotrophic lateral sclerosis(ALS), also known as Lou Gehrig’s disease – the motor neuron disease with Professor Stephen Hawking famously suffers from. It is the first new therapy for the condition in 22 years.

The ailment received public attention and fundraising efforts in 2014 in the form of social media phenomenon the ice bucket challenge – the money generated by the movement can now be seen to have been a significant help in battling the disease.

Radicava does not cure the disease, but has displayed its ability to slow its progression by up to 33% based on the ALS Functional Rating Scale-Revised and could extend the the average life expectancy from two to five, or even seven, years - a significant step in managing the ailment.  

The approval was processed by the US regulator on 5 May, coinciding nicely with ALS awareness month. Commercialisation of the product in the US will be handled by Mitsubishi Tanabe subsidiary MT Pharma America. Radicava had previously been approved in Japan for the treatment of the after-effects of ischemic stroke, and again in 2015 for ALS.   

"It's the first drug that meaningfully slows down the progression of the disease," commented Fred Fisher, President and CEO of the ALS Association. "It's likely now that people will be living longer with ALS and have a better quality of life."

Matt Fellows

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