The FDA has approved a new ALS drug that was backed by patients and advocacy groups. Its study had been partly funded by the viral Ice Bucket Challenge.
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.
In March, the Peripheral and Central Nervous System Drugs Advisory Committee voted 6-4 that a single Phase 2 trial did not establish the conclusion that the drug is effective in treating ALS. “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.
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