A panel of federal health advisers voted Wednesday to recommend approval for an experimental drug to treat Lou Gehrig's disease, a remarkable turnaround for the much-debated medication that was previously rejected by the same group.
“To deprive ALS patients of a drug that might work, it’s probably not something I would feel terribly comfortable with,” said Dr. Liana Apostolova of Indiana University’s School of Medicine, who voted for approval. “At the previous meeting it wasn’t that clear and it’s still questionable.”
Wednesday’s vote concluded a rare second meeting to review several new statistical analyses submitted by Amylyx in support of the treatment’s benefit in slowing disease and extending life. Dunn also noted that a larger Amylyx study being conducted in the U.S. and Europe could provide “more definitive results” by 2024.
Amylyx conducted one small, mid-stage trial of its drug that showed some benefit in slowing the disease, but it was plagued by missing data and other problems, according to“The final result — for a single study — is borderline and not very statistically persuasive,” FDA statistician Tristan Massie told panelists.
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