FDA grants priority review for Biogen & Eisai’s LEQEMBI™ lecanemab

Biogen and Eisai Co announced that the FDA has accepted their sBLA and has granted priority review for traditional approval of LEQEMBI™ (lecanemab) for treatment of Alzheimer’s disease.  It was approved under the Accelerated Approval Pathway on 6 January 2023 (approval based on ‘surrogate’ marker or endpoint). 

On 27 February 2023 the companies announced that LEQEMBI™ was designated for Priority Review by the NMPA in China. 

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