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

To get traditional approval, the Alzheimer’s treatment could see tightened labeling on the need to test for ApoE ε4 status given advisory committee recommendations. Some panelists also raised concerns around use with anticoagulants and in patients with cerebral amyloid angiopathy.

Leqembi vials and boxes
• Source: Eisai

A US Food and Drug Administration advisory committee unanimously backed conversion from accelerated to traditional 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

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