A much-debated drug for Lou Gehrig’s disease won U.S. approval on Thursday from the Food and Drug Administration.
won U.S. approval on Thursday from the Food and Drug Administration., though it is likely to renew questions about the scientific rigor behind government reviews of experimental medicines, as the Associated Press has reported.
Typically, the FDA requires two large studies or one study with "very persuasive" survival results for approval.It's the third U.S.-approved medicine for the treatment of— which destroys nerve cells needed for basic functions such as walking, talking and swallowing. Amylyx’s drug is the latest in a series of neurological drugs that have won FDA approval despite questionable effectiveness data, according to the AP.
In early Sept., FDA advisers — reversing a previous decision — voted to recommend approval of the drug. Recently, however, the FDA faced a great deal of pressure from ALS patients, advocates and members of Congress, the AP noted. FDA approval is expected to compel insurers to cover Amylyx’s medication.
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