FDA approves ALS drug whose study was partly funded by Ice Bucket Challenge | CNN

The FDA announced approval of Relyvrio, developed by Amylyx Pharmaceuticals, on Thursday. The oral medication works as a standalone therapy or when added to other treatments, according to the company, and it has been shown to slow disease progression. “This approval provides another important treatment option for ALS, a life-threatening disease that currently has no cure,” Dr.

“In terms of establishing the conclusion that it’s effective, we were asked to look for substantial evidence with persuasiveness and robustness and I think this one trial doesn’t quite meet that bar,” Dr. Kenneth Fischbeck, one of the committee members and an investigator at the National Institutes of Health, said at the March meeting. Fischbeck added that he has cared for ALS patients.

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