FDA headquarters (Aaron M. Sprecher via AP Images)
The FDA almost never pulls fully-approved drugs. Amylyx's ALS treatment might be the exception
Barring safety issues, the FDA almost never pulls fully-approved drugs from the market. But given the magnitude of the failure with Amylyx’s Phase III data in ALS, it may not have to.
Friday’s study readout — with a failed primary endpoint, a brutal p-value and misses on every secondary endpoint — is likely to give the company few options, especially with past promises to consider withdrawing the drug if this final-stage study didn’t work.
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