FDA releases contemporary particulars on inside debate over controversial Alzheimer’s drug

FDA releases contemporary particulars on inside debate over controversial Alzheimer’s drug

However in an interview Tuesday, appearing FDA commissioner Janet Woodcock, who stated she was not concerned within the approval, defended the method, saying she was “pretty assured” that lowering amyloid would assist sufferers’ cognition. She famous that below accelerated approval, officers can approve a drug primarily based on a surrogate endpoint — on this case, a discount in amyloid — whether it is “moderately doubtless” to provide a medical profit.

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