FDA panel overwhelmingly votes against experimental ALS treatment pushed by patients
CBSN
Federal health advisers voted overwhelmingly against an experimental treatment for Lou Gehrig's disease at a Wednesday meeting prompted by years of patient efforts seeking access to the unproven therapy.
The panel of Food and Drug Administration experts voted 17-1 that drugmaker Brainstorm's stem cell-based treatment has not been shown effective for patients with the fatal, muscle-wasting disease known as ALS, or amyotrophic lateral sclerosis. One panel member abstained from voting.
While the FDA is not bound by the vote, it largely aligns with the agency's own strikingly negative review released earlier this week, in which staff scientists described Brainstorm's application as "scientifically incomplete" and "grossly deficient."
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