Eisai Files Alzheimer’s Drug Lecanemab In Europe But Will EMA Grant Fast Track?
Accelerated Assessment Could Cut Months Off Review
Eisai and Biogen’s aducanumab was never approved in the European Union and while lecanemab is generating more confidence, a fast track review has not yet been confirmed.
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Despite being hailed as a potential breakthrough for Alzheimer’s, the EMA will not fast-track lecanemab, underscoring differences with the US FDA’s frequent use of accelerated pathways.
With accelerated approval granted and a supplemental filing for full approval in the FDA's hands, Eisai set a price it says is below the “societal value” its Alzheimer’s drug provides as it prepares to seek Medicare coverage. Labeling notably comes with no black box warning or safety restrictions despite various concerns.
A letter in the New England Journal of Medicine suggests the death of one extension trial participant treated with t-PA may have been caused by lecanemab, but a response notes fatal intracerebral hemorrhages have been seen after t-PA in certain patients in the absence of anti-amyloid drugs.