New ARIA cas­es dog Bio­gen's Aduhelm launch in an­oth­er po­ten­tial blow to block­buster hopes — an­a­lyst

Per­haps an­tic­i­pat­ing a walkover with an FDA ap­proval in hand, Bio­gen has in­stead faced a wall of push­back over its con­tro­ver­sial Alzheimer’s med Aduhelm. With pay­ers and clin­ics large­ly stay­ing away, Bio­gen’s drug is post­ing some trou­bling safe­ty sig­nals that could de­rail the launch even fur­ther.

In a note to clients Fri­day, an­a­lysts from Baird re­vealed new safe­ty da­ta from the FDA’s Ad­verse Event Re­port­ing Sys­tem (FAERS) show­ing a trou­bling re­cur­rence of ARIA in a crop of pa­tients who have been dosed with Aduhelm.

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