Wood­cock de­fends Bio­gen's new Alzheimer's drug, says it has more sup­port­ive da­ta than many past ac­cel­er­at­ed ap­provals

Act­ing FDA com­mis­sion­er Janet Wood­cock pub­licly de­fend­ed Bio­gen’s con­tro­ver­sial Alzheimer’s drug Aduhelm on Tues­day, say­ing it’s “a very sol­id” ac­cel­er­at­ed ap­proval, and “has a lot more sup­port­ive da­ta” than many oth­er drugs that have won ac­cel­er­at­ed ap­proval over the years.

While Wood­cock did not delve in­to which past ac­cel­er­at­ed ap­provals had less sup­port­ive da­ta than Aduhelm, she did ac­knowl­edge some “process prob­lems” with the Aduhelm ap­proval, not­ing that the ad­vi­so­ry com­mit­tee did not vote against Aduhelm be­ing ap­proved un­der the ac­cel­er­at­ed path­way. But she stopped short of men­tion­ing that the com­mit­tee was nev­er asked to con­sid­er an ac­cel­er­at­ed ap­proval, and mul­ti­ple FDA of­fi­cials as­sured the ad­comm pan­elists that an ac­cel­er­at­ed ap­proval wasn’t in the cards.

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