Eisai/Biogen’s Leqembi Breezes Through Adcomm; Labeling Discussions With US FDA May Be Knottier
Executive Summary
To get regular 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.
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