Up­dat­ed: FDA sig­nals like­ly full ap­proval for Ei­sai's new Alzheimer's drug ahead of Fri­day's ad­comm

The FDA said Wednes­day that the con­fir­ma­to­ry tri­al that Ei­sai and Bio­gen ran to show their new Alzheimer’s drug has a clin­i­cal ben­e­fit did in­deed have one, lin­ing Leqem­bi up for a like­ly full ap­proval next month af­ter get­ting an ac­cel­er­at­ed nod in Jan­u­ary.

Ahead of Fri­day’s ad­vi­so­ry com­mit­tee meet­ing, which fea­tures just six vot­ing mem­bers, FDA re­view­ers af­firmed what Ei­sai and Bio­gen said at the time about the re­sults of the con­fir­ma­to­ry tri­al, known as CLAR­I­TY AD, adding that:

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