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.
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Labeling for the first anti-amyloid to receive traditional approval in Alzheimer’s disease states that testing for ApoE ε4 status ‘should be performed’ prior to treatment; updated labeling also includes stronger cautionary language on use in patients with risk factors for cerebral hemorrhage.
New details from CMS about the information that providers will be required to submit for Medicare beneficiaries taking anti-amyloid Alzheimer’s drugs indicate the agency could have a hard time getting answers to some of the key questions outlined in its National Coverage Determination.
US FDA agrees with Eisai/Biogen that half a point change in cognitive scale, which sponsor says means a five month delay in decline, is a clinically meaningful benefit. But others contend the treatment effect is small and does not outweigh risk of brain bleeds.