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FDA approves new ALS drug funded in part by Ice Bucket Challenge

The U.S. Food and Drug Administration has approved a drug that has been shown to slow the progression of amyotrophic lateral sclerosis (ALS), eight years after people dumped ice water on each other’s heads to raise money that helped fund the drug’s testing.

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The ALS Association announced the approval on Thursday afternoon.

It is the first drug that the FDA has approved for ALS, sometime referred to Lou Gehrig’s disease, in five years, according to the Wall Street Journal.

A Boston drug maker, Amylyx Pharmaceuticals, developed the drug AMX0035 in part by using funds raised by the social media ALS Ice Bucket Challenge.

The challenge involved dumping buckets of ice water on someone’s head. Participants would challenge others to either dump a bucket of ice water over their own head and donate $10 to the ALS Association or skip the water dump and donate $100 to the association.

If you were challenged, you had 24 hours to complete the challenge and you had to upload a video as proof you completed the challenge. Participants then tagged another person to take the challenge.

“If not for the Ice Bucket Challenge, we wouldn’t be here,” Justin Klee, co-CEO and co-founder of Amylyx, said.

The drug has already been approved for use in Canada.

ALS is a progressive and fatal neurodegenerative disorder. Around 30,000 people are diagnosed with the disorder in the U.S. each year.

While Amylyx officials stress that the drug is not a cure, results from testing have been very encouraging.

“Our trial showed a statistically significant slowing in the rate of disease progression,” said Josh Cohen, co-CEO and co-founder of Amylyx. “People progressed about 25% slower when they were on the drug as compared to placebo.

“We also saw that people who were on the drug survived longer than those who were taking the placebo, as well,” he added. “We saw a benefit on both function and survival.”

Cohen said that a decade ago when he began research into ALS treatments, funds were difficult to find. The ALS Ice Bucket Challenge generated enough money to allow for a $3 million grant for the research that led to AMX0035.

An FDA advisory committee — the Peripheral and Central Nervous System Drugs Advisory Committee — has already said that according to the available evidence, the agency should support the approval of AMX0035 for the treatment of ALS.

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