If you thought the FDA’s ap­proval of Aduhelm for Alzheimer’s was con­tro­ver­sial, you should hear the ex­pert­s' thoughts on off-la­bel use

When the FDA grant­ed Bio­gen an ac­cel­er­at­ed ap­proval for Bio­gen’s Aduhelm, it wasn’t just Alzheimer’s pa­tients who got their hopes up.

There is, for in­stance, a re­lat­ed con­di­tion called cere­bral amy­loid an­giopa­thy (CAA) — which, like Alzheimer’s, is thought to be trig­gered by ac­cu­mu­la­tion of be­ta amy­loid de­posits. The dif­fer­ence is that the amy­loid is de­posit­ed in ves­sels in the brain rather than as plaques, po­ten­tial­ly lead­ing to bleed­ing and in­jury. And pa­tients want­ed to know: Since Aduhelm was ap­proved on its abil­i­ty to clear the very same pro­tein that’s caus­ing their dis­ease, should they be tak­ing it off-la­bel?

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