Eisai/Biogen’s Leqembi: US FDA’s Full Approval Comes With A Boxed Warning On ARIA Risk
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.
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Medicare policymakers have felt that without an effective approved treatment, coverage of amyloid PET scans and APOE4 genetic tests was not warranted. But that is changing.
Required studies will assess the risks of ARIA and intracerebral hemorrhage, as well as safety in ApoE ε4 homozygotes. For the required registry-based study, the FDA suggests use of the ALZ-NET platform with no mention of CMS’ newly established registry, which may lack the level of detailed information needed to satisfy the drug regulator’s request.
Ability to use beta amyloid plaque reduction to support a traditional approval in Alzheimer’s, or for use with other drug classes, needs to be evaluated case-by-case based on the available data, agency says. In the HIV/AIDS space, it took FDA decades to declare a surrogate endpoint validated.