No Fast Track For Lecanemab In EU Disappoints Eisai
Pan-EU Approval Could Come In March 2024, Says Company
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.
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Eisai Files Alzheimer’s Drug Lecanemab In Europe But Will EMA Grant Fast Track?
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.
Eisai’s Lecanemab: US FDA Showed Flexibility On Clinical Endpoint Results, Safety Database Size
Alzheimer’s drug’s failure to meet Phase II endpoint did not preclude accelerated approval in light of statistically significant reduction in amyloid plaque and ‘generally consistent and favorable results on clinical endpoints.’ Size of six-month safety database also fell shy of ICH guidelines.