Eisai/Biogen’s Leqembi Breezes Through Adcomm; Labeling Discussions With US FDA May Be Knottier

A US Food and Drug Administration advisory committee unanimously backed conversion from accelerated to regular approval for Eisai Co., Ltd. and Biogen, Inc.’s Alzheimer’s drug Leqembi (lecanemab-irmb), but panelists’ recommendations aimed at addressing safety concerns in some patient subgroups could result in tighter labeling for the anti-amyloid agent.

On the lone voting question, all six members of the Peripheral and Central Nervous System Drugs Advisory Committee on 9 June said the results from the Phase III CLARITY AD trial (also known as Study 301) verify