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Friday, the FDA's Peripheral and Central Nervous System Drugs Advisory Committee voted unanimously that the data from Eisai Co Ltd (OTC:ESALY) and Biogen Inc (NASDAQ:BIIB) Phase 3 Clarity AD trial confirms the clinical benefit of Leqembi (lecanemab) for Alzheimer's disease.
Additionally, the committee members confirmed the overall benefit-risk profile of Leqembi, and the clinical meaningfulness of the data.
The advisers discussed the risk of using Leqembi in certain patients, like those taking drugs that prevent blood clots and those with cerebral amyloid angiopathy, a rare neurological condition in which amyloid protein builds up on the walls of the arteries in the brain.
Also Read: Bernie Sanders Takes on High Costs of Alzheimer's Treatment Leqembi, Calls Price Tag 'Unconscionable'.
William Blair writes that while the agency acknowledged and discussed additional risk/benefit considerations in the various subgroups, the use will largely be left in the hands of physician-patient discussions and the relevant warnings listed in the current Leqembi label under accelerated approval to remain largely unchanged if full approval is granted.
The analyst remains bullish on the full approval prospects of Leqembi by the July 6 PDUFA date, given the overwhelmingly positive AdCom support of confirmatory evidence from the CLARITY-AD study with limited expectations for major label amendments regarding subgroup risks.
Price Action: BIIB shares are down 4.50% at $313.25 on the last check Monday.
