Seiz­ing Aduhelm prece­dent, Bio­gen, Ei­sai get the ball rolling on an­oth­er ac­cel­er­at­ed Alzheimer's ap­proval

Bio­gen — to­geth­er with part­ners at Ei­sai — will be the first to breeze down that Alzheimer’s trail it blazed with the FDA’s his­toric and con­tro­ver­sial ac­cel­er­at­ed ap­proval of Aduhelm.

Ei­sai dis­closed it’s ini­ti­at­ed a rolling BLA sub­mis­sion for lecanemab, or BAN2401, the an­ti-amy­loid be­ta an­ti­body that Bio­gen has long tout­ed as a fol­low-on to Aduhelm (then ad­u­canum­ab). Fol­low­ing the prece­dent that the agency has now set, the two com­pa­nies are gun­ning for an OK based on da­ta sug­gest­ing that the drug could low­er amy­loid be­ta plaques.

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