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FDA Advisory Panel Votes in Favor of Full Approval for Lecanemab

FDAOn June 9, The US Food and Drug Administration convened members of the updated Peripheral and Central Nervous System Drugs Advisory Committee to review the available data for lecanemab, the monoclonal antibody treatment for early Alzheimer’s disease developed by Eisai and Biogen. The members voted unanimously, 6-0, in favor of approval.

Lecanemab was recently granted accelerated approval by FDA, based on demonstration that treatment with the infused medication could lower brain amyloid levels. Based on results from a large Phase 3 trial in which lecanemab demonstrated efficacy in slowing disease progression over 18-months, the agency will now consider full approval for the drug. This would be the first full approval for a class of medicines that can lower amyloid burden in the brain, and the first full approval for any new medicine for Alzheimer’s disease in many years. A decision from the FDA whether to grant full approval is expected by July 6.

The approval could clear the way to increase access to lecanemab and, hopefully, coverage. A key unknown is how, or whether, the Centers for Medicare and Medicaid Services (CMS) will adjust their approach to paying for the approved amyloid-lowering drugs. Currently, the agency has agreed to coverage only in the setting of rigorous controlled clinical trials. But with full approval, they could adjust their restrictions, perhaps providing coverage, provided that patients are entered into a lower-burden registry that permits tracking of safety outcomes. It is important to note that treatment with these medications requires biomarker testing to confirm appropriateness for therapy, and genetic testing to fully inform patients and families about treatment risks (risks of side effects are higher in people carrying particular genes). Coverage decisions related to these tests, as well as MRIs needed to ensure ongoing safety while being treated, will also be key.