Bio­gen in­ves­ti­gates a death pos­si­bly linked to its con­tro­ver­sial new Alzheimer's drug

Bio­gen is in­ves­ti­gat­ing the death of a 75-year-old pa­tient po­ten­tial­ly linked to the com­pa­ny’s new Alzheimer’s drug, which the FDA con­tro­ver­sial­ly ap­proved via its ac­cel­er­at­ed path­way with lim­it­ed ev­i­dence that the drug ac­tu­al­ly ben­e­fits those suf­fer­ing from the mem­o­ry wast­ing dis­ease.

The com­pa­ny told End­points News in an emailed state­ment that it’s care­ful­ly re­view­ing all ad­verse events re­ports, med­ica­tion er­ror re­ports, and prod­uct com­plaints pub­lished in FDA’s Ad­verse Event Re­port­ing Sys­tem, “in­clud­ing the fa­tal case of a 75-year-old pa­tient whose cause of death re­mains un­der in­ves­ti­ga­tion and who was di­ag­nosed dur­ing hos­pi­tal­iza­tion with cere­bral ede­ma thought to be ARIA-E. We con­tin­ue to work with the re­port­ing physi­cian as well as glob­al reg­u­la­tors to fur­ther un­der­stand the case. Alzheimer’s dis­ease is com­plex, and pa­tients af­fect­ed by this dev­as­tat­ing dis­ease of­ten suf­fer from oth­er se­ri­ous med­ical con­di­tions.”

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