Alzheimer's ex­perts call on FDA to pull Bio­gen's Aduhelm

Alzheimer’s dis­ease re­searchers along with med­ical pro­fes­sors from Har­vard and Johns Hop­kins is­sued a for­mal state­ment Mon­day ask­ing the FDA to quick­ly pull Bio­gen’s Aduhelm from the mar­ket.

“An ac­cel­er­at­ed with­draw­al would mit­i­gate some of the harm of its un­war­rant­ed ac­cel­er­at­ed ap­proval,” they wrote to FDA, ex­plain­ing how Aduhelm “did not meet the FDA’s own cri­te­ria for ac­cel­er­at­ed ap­proval based on sur­ro­gate mark­ers be­cause amy­loid plaque does not cor­re­late well with symp­toms, sever­i­ty of dis­ease or pro­gres­sion.”

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